Trial Outcomes & Findings for Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic (NCT NCT02721732)

Last Updated: 2026-01-29

Results Overview

Non-progression rate (NPR) at 27 weeks was defined as the percentage of efficacy evaluable patients who were alive and progression-free at 27 weeks as assessed by irRECIST Progression is defined using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST), as an increase ≥ 20% (minimum 5 mm) in total measured tumor burden compared with nadir or progression of non-target lesions or new lesion

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

157 participants

Primary outcome timeframe

At 27 weeks

Results posted on

2026-01-29

Participant Flow

This is a single-center, open-label, phase II trial of pembrolizumab (MK-3475) in patients with and without programmed death-ligand 1 (PD-L1) positive advanced tumors conducted at the University of Texas MD Anderson Cancer Center

Participant milestones

Participant milestones
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Overall Study STARTED	20	12	24	5	29	3	11	12	13	28
Overall Study COMPLETED	3	0	2	0	3	0	0	0	2	3
Overall Study NOT COMPLETED	17	12	22	5	26	3	11	12	11	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Overall Study Adverse Event	2	0	2	0	1	0	1	0	1	1
Overall Study Death	0	0	0	0	1	0	1	0	0	1
Overall Study Lack of Efficacy	12	11	18	5	21	2	8	11	10	20
Overall Study Physician Decision	0	0	1	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	1	0	0	0	3	0	1	1	0	1
Overall Study Participant Choice	1	0	0	0	0	0	0	0	0	1
Overall Study Progression and Exclusion from study due to changed diagnosis	0	0	1	0	0	0	0	0	0	0
Overall Study Progression and withdrew consent	1	1	0	0	0	0	0	0	0	1
Overall Study No evidence of tumor following radical surgery	0	0	0	0	0	1	0	0	0	0

Baseline Characteristics

Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=20 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin n=12 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma n=24 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma n=5 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary n=29 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma n=3 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma n=11 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor n=12 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma n=13 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies n=28 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Total n=157 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=528 Participants	0 Participants n=590 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=35 Participants	10 Participants n=4328 Participants	20 Participants n=8687 Participants	5 Participants n=153 Participants	15 Participants n=200 Participants	0 Participants n=12 Participants	5 Participants n=4 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	21 Participants n=528 Participants	106 Participants n=590 Participants
Age, Categorical >=65 years	14 Participants n=35 Participants	2 Participants n=4328 Participants	4 Participants n=8687 Participants	0 Participants n=153 Participants	14 Participants n=200 Participants	3 Participants n=12 Participants	6 Participants n=4 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=528 Participants	51 Participants n=590 Participants
Sex: Female, Male Female	3 Participants n=35 Participants	7 Participants n=4328 Participants	14 Participants n=8687 Participants	1 Participants n=153 Participants	21 Participants n=200 Participants	0 Participants n=12 Participants	4 Participants n=4 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=528 Participants	76 Participants n=590 Participants
Sex: Female, Male Male	17 Participants n=35 Participants	5 Participants n=4328 Participants	10 Participants n=8687 Participants	4 Participants n=153 Participants	8 Participants n=200 Participants	3 Participants n=12 Participants	7 Participants n=4 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=528 Participants	81 Participants n=590 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=35 Participants	3 Participants n=4328 Participants	1 Participants n=8687 Participants	0 Participants n=153 Participants	2 Participants n=200 Participants	1 Participants n=12 Participants	0 Participants n=4 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=528 Participants	16 Participants n=590 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=35 Participants	9 Participants n=4328 Participants	22 Participants n=8687 Participants	5 Participants n=153 Participants	25 Participants n=200 Participants	2 Participants n=12 Participants	11 Participants n=4 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	24 Participants n=528 Participants	138 Participants n=590 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants	0 Participants n=153 Participants	2 Participants n=200 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=528 Participants	3 Participants n=590 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=528 Participants	0 Participants n=590 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=4328 Participants	3 Participants n=8687 Participants	0 Participants n=153 Participants	1 Participants n=200 Participants	1 Participants n=12 Participants	1 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=528 Participants	8 Participants n=590 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=528 Participants	0 Participants n=590 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants	3 Participants n=153 Participants	3 Participants n=200 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=528 Participants	12 Participants n=590 Participants
Race (NIH/OMB) White	20 Participants n=35 Participants	10 Participants n=4328 Participants	19 Participants n=8687 Participants	1 Participants n=153 Participants	22 Participants n=200 Participants	2 Participants n=12 Participants	8 Participants n=4 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	18 Participants n=528 Participants	118 Participants n=590 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	1 Participants n=153 Participants	0 Participants n=200 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=528 Participants	1 Participants n=590 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	2 Participants n=4328 Participants	1 Participants n=8687 Participants	0 Participants n=153 Participants	3 Participants n=200 Participants	0 Participants n=12 Participants	2 Participants n=4 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=528 Participants	18 Participants n=590 Participants
Region of Enrollment United States	20 participants n=35 Participants	12 participants n=4328 Participants	24 participants n=8687 Participants	5 participants n=153 Participants	29 participants n=200 Participants	3 participants n=12 Participants	11 participants n=4 Participants	12 participants n=5 Participants	13 participants n=4 Participants	28 participants n=528 Participants	157 participants n=590 Participants

PRIMARY outcome

Timeframe: At 27 weeks

Population: All patients who have received at least 1 dose of study medication with at least 1on-study tumor assessment were included in the analysis. If a patient discontinued before the first radiological assessment due to progression, they were included in the analysis. If the patient discontinued before 27 weeks due to reasons other than progression or death, they were considered non evaluable for this endpoint. One patient enrolled in the ACC cohort was excluded due to change in diagnosis.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=17 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin n=12 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma n=20 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma n=5 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary n=26 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma n=2 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma n=10 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor n=11 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma n=12 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies n=27 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Non-progression Rate (NPR) at 27 Weeks by irRECIST	7 Participants	0 Participants	6 Participants	0 Participants	8 Participants	0 Participants	2 Participants	1 Participants	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.

Population: PD-L1 expression on tumor and mononuclear inflammatory cells in tumor nests were assessed on samples obtained prior to treatment. Patients with PD-L1 positive disease (CPS ≥1) were evaluated for objective response.

Immune-related ORR is defined as the percentage of patients achieving a irCR or irPR based on irRECIST criteria. PD-L1 positivity was defined as Combined Positive Score ≥1. Evaluated objective response in PD-L1 positive patients Per irRECIST: Immune-related (ir) Complete Response (irCR), disappearance of all target and non-target lesions, nodal short axis diameter \<10 mm, no new lesions; irPartial Response (irPR), decrease of ≥30% in tumor burden relative to baseline, non-unequivocal progression of non-target lesions, no new lesions.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=14 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin n=6 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma n=2 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma n=4 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary n=16 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma n=2 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma n=6 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor n=3 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma n=5 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies n=14 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Evaluation of Tumor Size (Objective Response by irRECIST) to PD-L1 Status (CPS ≥1)	6 Participants	0 Participants	1 Participants	0 Participants	5 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: First day of administration of study medication through 30 days following last dose, an average of 4 years.

Population: It was a pre-specified objective. All patients who have received at least 1 dose of study medication were included in the safety analysis. A total of 157 patients were treated on this study. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis following histological assessment of the surgical specimen.

Per protocol, the number and percentage of patients with any treatment-related AE was summarized for all study patients combined. Patients were monitored for AE from the first day of administration of study medication through 30 days following last dose. Each AE (as defined by NCI CTCAE v4.03) was counted only once for a given subject. In the event a patient experienced repeated episodes of the same AE, then the event with the highest severity and/or strongest causal relationship to study treatment was used for purposes of tabulations.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=156 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Number of Patients Who Experienced Treatment-related Adverse Event (TRAE)	88 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.

Population: All patients who have received at least 1 dose of study medication with at least one adequate on-study tumor assessment were included in the efficacy analysis. If a patient discontinued the study before the first radiological assessment due to progression of disease, either radiological or clinical, they were considered evaluable and were included in the efficacy analysis. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis.

ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=18 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin n=12 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma n=20 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma n=5 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary n=26 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma n=3 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma n=10 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor n=11 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma n=13 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies n=28 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	6 Participants	0 Participants	4 Participants	0 Participants	5 Participants	1 Participants	1 Participants	0 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.

CBR is defined as the percentage of patients achieving a CR or PR, or stable disease (SD) ≥4 months based on RECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=18 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin n=12 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma n=20 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma n=5 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary n=26 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma n=3 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma n=10 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor n=11 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma n=13 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies n=28 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Clinical Benefit Rate (CBR) Using RECIST v1.1	7 Participants	0 Participants	11 Participants	0 Participants	10 Participants	1 Participants	3 Participants	2 Participants	7 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.

PFS was defined as the time from administration of the first dose to the first documented disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=146 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Progression-free Survival (PFS) Using RECIST v1.1	2.2 months Interval 2.0 to 2.7	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.

Immune-related ORR is defined as the percentage of patients achieving a irCR or irPR based on irRECIST criteria.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=18 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin n=12 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma n=20 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma n=5 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary n=26 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma n=3 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma n=10 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor n=11 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma n=13 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies n=28 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Immune-related ORR Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)	6 Participants	0 Participants	4 Participants	0 Participants	5 Participants	1 Participants	1 Participants	0 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: First day of administration of study medication through 30 days following last dose, an average of 4 years.

Immune-related CBR is defined as the percentage of patients achieving a irCR or irPR, or irSD ≥4 months based on irRECIST criteria

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=18 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin n=12 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma n=20 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma n=5 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary n=26 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma n=3 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma n=10 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor n=11 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma n=13 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies n=28 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Immune-related Clinical Benefit Rate (CBR) Using irRECIST	8 Participants	0 Participants	11 Participants	0 Participants	12 Participants	1 Participants	3 Participants	2 Participants	7 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks.

Immune-related PFS was defined as the time from administration of the first dose to the first documented disease progression according to irRECIST or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous Cell Carcinoma of the Skin n=146 Participants MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 2: Small Cell Malignancies of Nonpulmonary Origin MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 3: Adrenocortical Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 4: Medullary Renal Cell Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 5: Carcinoma of Unknown Primary MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 6: Penile Carcinoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 7: Vascular Sarcoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 8: Germ Cell Tumor MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 9: Paraganglioma-pheochromocytoma MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle	Cohort 10: Other Rare Tumor Histologies MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
Immune-related Progression-free Survival (PFS) Using irRECIST	2.3 months Interval 2.0 to 3.6	—	—	—	—	—	—	—	—	—

Adverse Events

Participants With Advanced Rare Cancer

Serious events: 72 serious events

Other events: 84 other events

Deaths: 114 deaths

Serious adverse events

Serious adverse events
Measure	Participants With Advanced Rare Cancer n=156 participants at risk "MK-3475: 200 mg IV on Day 1 of every 21-day cycle Of the 157 participants enrolled, one participant in ACC cohort was excluded due to change in the diagnosis."
Gastrointestinal disorders Abdominal pain	5.1% 8/156 • Number of events 8 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 6/156 • Number of events 6 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Fever	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Lung infection	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Blood and lymphatic system disorders Anemia	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Back pain	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Fatigue	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Acute kidney injury	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Aspartate aminotransferase increased	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Hematoma	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hyperglycemia	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hyponatremia	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Hypotension	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Nervous system disorders - Other, specify	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Non-cardiac chest pain	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Small intestinal obstruction	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Endocrine disorders Adrenal insufficiency	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Alanine aminotransferase increased	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Atrial fibrillation	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Autoimmune disorder (hepatitis)	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Blood bilirubin increased	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Chest pain - cardiac	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Death NOS	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Diarrhea	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Dizziness	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Dysphagia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Edema face	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Injury, poisoning and procedural complications Fall	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Flank pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Injury, poisoning and procedural complications Fracture	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Gait disturbance	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Gastritis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders General disorders and administration site conditions - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Headache	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Hepatobiliary disorders Hepatic hemorrhage	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypercalcemia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hyperkalemia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Hypertension	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Endocrine disorders Hyperthyroidism	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Blood and lymphatic system disorders Leukocytosis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders NOS, Neoplasms benign,malignant and unspecified (incl cysts and polyps) -Other,	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Nausea	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign,malignant and unspecified (incl cysts and polyps) -Other, specify-Tumor bleeding	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Psychiatric disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify-Altered mental	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Pain in extremity	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Renal and urinary disorders - Other, specify-acute renal failure	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Sepsis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Sinus tachycardia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Skin infection	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Stridor	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Superior vena cava syndrome	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Transient ischemic attacks	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Tremor	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Urinary retention	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Urinary tract infection	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Vomiting	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.

Other adverse events

Other adverse events
Measure	Participants With Advanced Rare Cancer n=156 participants at risk "MK-3475: 200 mg IV on Day 1 of every 21-day cycle Of the 157 participants enrolled, one participant in ACC cohort was excluded due to change in the diagnosis."
Skin and subcutaneous tissue disorders Rash	3.8% 6/156 • Number of events 6 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Fatigue	35.3% 55/156 • Number of events 55 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Blood and lymphatic system disorders Anemia	33.3% 52/156 • Number of events 52 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Constipation	26.3% 41/156 • Number of events 41 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Creatinine increased	22.4% 35/156 • Number of events 35 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Aspartate aminotransferase increased	20.5% 32/156 • Number of events 32 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Alanine aminotransferase increased	19.9% 31/156 • Number of events 31 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Rash maculo-papular	19.9% 31/156 • Number of events 31 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Alkaline phosphatase increased	17.9% 28/156 • Number of events 28 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Nausea	17.9% 28/156 • Number of events 28 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Endocrine disorders Hypothyroidism	17.3% 27/156 • Number of events 27 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 26/156 • Number of events 26 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hyperglycemia	16.0% 25/156 • Number of events 25 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Anorexia	15.4% 24/156 • Number of events 24 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Diarrhea	15.4% 24/156 • Number of events 24 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypomagnesemia	15.4% 24/156 • Number of events 24 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hyperkalemia	14.1% 22/156 • Number of events 22 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Cough	13.5% 21/156 • Number of events 21 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hyperuricemia	11.5% 18/156 • Number of events 18 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hyponatremia	10.3% 16/156 • Number of events 16 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypercalcemia	9.0% 14/156 • Number of events 14 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Headache	8.3% 13/156 • Number of events 13 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Peripheral sensory neuropathy	8.3% 13/156 • Number of events 13 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Platelet count decreased	8.3% 13/156 • Number of events 13 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Edema limbs	7.7% 12/156 • Number of events 12 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Pain	7.7% 12/156 • Number of events 12 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Back pain	7.7% 12/156 • Number of events 12 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypokalemia	7.1% 11/156 • Number of events 11 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Myalgia	6.4% 10/156 • Number of events 10 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Pain in extremity	6.4% 10/156 • Number of events 10 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Renal and urinary disorders - Other, specify	6.4% 10/156 • Number of events 10 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	6.4% 10/156 • Number of events 10 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Upper respiratory infection	6.4% 10/156 • Number of events 10 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Abdominal pain	5.8% 9/156 • Number of events 9 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Fever	5.8% 9/156 • Number of events 9 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Hypotension	5.8% 9/156 • Number of events 9 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Psychiatric disorders Insomnia	5.8% 9/156 • Number of events 9 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Pruritus	5.8% 9/156 • Number of events 9 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Vomiting	5.8% 9/156 • Number of events 9 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations White blood cell decreased	5.8% 9/156 • Number of events 9 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Activated partial thromboplastin time prolonged	5.1% 8/156 • Number of events 8 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 8/156 • Number of events 8 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders General disorders and administration site conditions - Other, specify	5.1% 8/156 • Number of events 8 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Blood bilirubin increased	4.5% 7/156 • Number of events 7 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Hypertension	4.5% 7/156 • Number of events 7 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	4.5% 7/156 • Number of events 7 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Endocrine disorders Hyperthyroidism	3.8% 6/156 • Number of events 6 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypophosphatemia	3.8% 6/156 • Number of events 6 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Investigations - Other, specify	3.8% 6/156 • Number of events 6 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Urinary tract infection	3.8% 6/156 • Number of events 6 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypoalbuminemia	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Lymphocyte count decreased	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Mucositis oral	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	3.2% 5/156 • Number of events 5 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Psychiatric disorders Anxiety	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Arthritis	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Dysphagia	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Endocrine disorders Endocrine disorders - Other, specify	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Eye disorders Eye disorders - Other, specify	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations INR increased	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Lung infection	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Nervous system disorders - Other, specify	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Neutrophil count decreased	2.6% 4/156 • Number of events 4 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Abdominal distension	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Acute kidney injury	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Alopecia	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Eye disorders Blurred vision	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Dry mouth	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Dry skin	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Injury, poisoning and procedural complications Fall	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Flank pain	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypernatremia	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Infections and infestations - Other, specify	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Sinus tachycardia	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Surgical and medical procedures Surgical and medical procedures - Other, specify	1.9% 3/156 • Number of events 3 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Bone pain	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Cardiac disorders - Other, specify	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Chest pain - cardiac	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Chills	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Psychiatric disorders Depression	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Dizziness	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Ear and labyrinth disorders Hearing impaired	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypoglycemia	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Blood and lymphatic system disorders Leukocytosis	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Localized edema	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Neck pain	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Pharyngitis	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Productive cough	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Proteinuria	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Rash acneiform	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Sinus bradycardia	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Sinusitis	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Skin infection	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Skin ulceration	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Vaginal infection	1.3% 2/156 • Number of events 2 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Avascular necrosis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Bladder spasm	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Bullous dermatitis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Injury, poisoning and procedural complications Burn	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Chest wall pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Cholesterol high	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Colitis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Psychiatric disorders Confusion	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Dysgeusia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Dyspepsia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Ear and labyrinth disorders Ear pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Edema face	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Erythema	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Esophagitis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Gastroesophageal reflux disease	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Reproductive system and breast disorders Genital edema	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Gingival pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Hair loss to armpits and legs	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Heart failure	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Hematuria	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Hemorrhoids	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Hiccups	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Hot flashes	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Hypocalcemia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Increased PTT	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Increased Prothrombin time	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Injury, poisoning and procedural complications Intestinal stoma site bleeding	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Joint pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Leg swelling	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Lymphedema	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Memory impairment	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Reproductive system and breast disorders Menorrhagia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Mucosal infection	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Nail loss	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Neuralgia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Neuropathy	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
General disorders Non-cardiac chest pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Numbness	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Otitis media	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Cardiac disorders Palpitations	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Eye disorders Papilledema	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Periodontal disease	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Peripheral nerve infection	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Metabolism and nutrition disorders Poor appetite	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Reproductive system and breast disorders Prostatic obstruction	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Psychiatric disorders Psychiatric disorders - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Renal calculi	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Seizure	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Sore throat	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Superficial thrombophlebitis	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Syncope	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Reproductive system and breast disorders Testicular disorder	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Reproductive system and breast disorders Testicular pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Ear and labyrinth disorders Tinnitus	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Tooth development disorder	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Tooth infection	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Gastrointestinal disorders Toothache	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Nervous system disorders Tremor	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Urinary incontinence	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Urinary retention	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Urinary tract obstruction	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Urinary tract pain	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Renal and urinary disorders Urinary urgency	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Skin and subcutaneous tissue disorders Urticaria	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Vascular disorders Vascular disorders - Other, specify	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Eye disorders Watering eyes	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Investigations Weight loss	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Respiratory, thoracic and mediastinal disorders Wheezing	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Injury, poisoning and procedural complications Wound complication	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
Infections and infestations Wound infection	0.64% 1/156 • Number of events 1 • First day of administration of study medication through 30 days following last dose. All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.

Additional Information

Dr. Aung Naing

The University of Texas MD Anderson Cancer Center

Phone: (713) 563-3885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place