Trial Outcomes & Findings for Study of Pembrolizumab and Concurrent Radiation in Patients With Previously Treated Carcinoma of Unknown Primary (NCT NCT03396471)

Last Updated: 2024-04-18

Results Overview

Evaluate the abscopal response rate in Carcinoma of Unknown Primary (CUP) patients treated with the combination of pembrolizumab plus radiotherapy. Best abscopal response is defined as the frequency of patients whose best responding abscopal lesion demonstrates at least a 30% decrease in its longest diameter from baseline (Golden et al., 2015).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

From Cycle 3, Day 1 (each cycle is 21 days) (C3D1) until death or up to a maximum of 19 months

Results posted on

2024-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from Cycle 1 Day 1 (C1D1) can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Study Treatment - Up to 22 Months STARTED	14
Study Treatment - Up to 22 Months COMPLETED	0
Study Treatment - Up to 22 Months NOT COMPLETED	14
Follow up - Up to 2 Years STARTED	14
Follow up - Up to 2 Years COMPLETED	0
Follow up - Up to 2 Years NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from Cycle 1 Day 1 (C1D1) can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Study Treatment - Up to 22 Months Disease Progression	6
Study Treatment - Up to 22 Months Alternative Cancer Therapy	2
Study Treatment - Up to 22 Months AE / Side Effects / Complications	3
Study Treatment - Up to 22 Months Death	2
Study Treatment - Up to 22 Months Symptomatic Deterioration	1
Follow up - Up to 2 Years Death	9
Follow up - Up to 2 Years Patient lost to follow up	1
Follow up - Up to 2 Years Patient Refused to follow up	1
Follow up - Up to 2 Years study terminated	1
Follow up - Up to 2 Years Patient would like to seek treatments locally.	1
Follow up - Up to 2 Years Patient stopped protocol treatment due to lack of response to treatment regimen.	1

Baseline Characteristics

Study of Pembrolizumab and Concurrent Radiation in Patients With Previously Treated Carcinoma of Unknown Primary

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 Participants Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Age, Continuous	55.0 years n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Histology Adenocarcinoma	6 Participants n=93 Participants
Histology Carcinoma, NOS	4 Participants n=93 Participants
Histology Squamous Carcinoma	4 Participants n=93 Participants
Bone involvement Yes	5 Participants n=93 Participants
Bone involvement No	9 Participants n=93 Participants
Thoracic involvement Yes	9 Participants n=93 Participants
Thoracic involvement No	5 Participants n=93 Participants
Abdominal/Pelvic involvement Yes	13 Participants n=93 Participants
Abdominal/Pelvic involvement No	1 Participants n=93 Participants
Total number of metastatic sites	3 number of sites n=93 Participants

PRIMARY outcome

Timeframe: From Cycle 3, Day 1 (each cycle is 21 days) (C3D1) until death or up to a maximum of 19 months

Outcome measures

Outcome measures
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 Participants Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Abscopal Response Rate	7.1 percentage of participants Interval 0.2 to 33.9

SECONDARY outcome

Timeframe: From Cycle 1, Day 1 (each cycle is 21 days) until death or up to a maximum of 19 months

To determine the response rate by RECIST 1.1 and informed by irRECIST, of non-irradiated metastatic sites when pembrolizumab is combined with radiotherapy. Subjects with confirmed CR or PR per RECIST 1.1 should be considered. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 Participants Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Response Rate	0 Participants

SECONDARY outcome

Timeframe: From Cycle 1, Day 1 (each cycle is 21 days) until death or up to a maximum of 9 months

The maximum grade for each type of adverse event will be summarized using CTCAE version 4.0 criteria. The frequency and percentage of grade 2+ adverse events will be summarized using CTCAE version 4.0 criteria.

Outcome measures

Outcome measures
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 Participants Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Evaluate Treatment-related Toxicity. Number of patients had at least one grade 3 or greater adverse event	8 Participants
Evaluate Treatment-related Toxicity. Number of patients had at least one grade 3 or greater treatment related adverse event	5 Participants
Evaluate Treatment-related Toxicity. Number of patients having serious adverse event	7 Participants
Evaluate Treatment-related Toxicity. Number of patients had at least one adverse event of any grade	14 Participants

SECONDARY outcome

Timeframe: From Cycle 1, Day 1 (each cycle is 21 days) until progression or death or up to a maximum of 6 months

Progression-free survival (PFS) is defined as the time from registration to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria. Patients that are alive and progression-free will be censored on their last tumor evaluation date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 Participants Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Progression-Free Survival	2.2 months Interval 2.0 to upper limit was not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From Cycle 1, Day 1 (each cycle is 21 days) until death or up to a maximum of 19 months

Overall Survival (OS) is defined as the time from registration to death from any cause. Subjects who did not die will be censored at their last visit.

Outcome measures

Outcome measures
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 Participants Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Overall Survival	8.2 months Interval 2.4 to upper limit was not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From Cycle 1, Day 1 (each cycle is 21 days) until death or up to a maximum of 6 months

Time-to-Progression (TTP) is defined as the time from registration to disease progression, where patients that are progression-free will be censored on their last tumor evaluation date.

Outcome measures

Outcome measures
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 Participants Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Time-to-Progression	3.5 months Interval 2.0 to upper limit was not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From Cycle 1, Day 1 (each cycle is 21 days) to a maximum of 19 months

Disease Control Rate (DCR) is defined as the frequency (%) of patients who have a best response of PR, CR, or Stable disease based on RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum of the longest diameter since the treatment started.

Outcome measures

Outcome measures
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 Participants Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Disease Control Rate	35.7 percentage of participants Interval 12.8 to 64.9

SECONDARY outcome

Timeframe: From Cycle 1, Day 1 (each cycle is 21 days) until death or up to a maximum of 19 months

Population: Per RECIST 1.1 criteria, no confirmed CR or PR responses were observed.

The association between RR (using RECIST 1.1 (informed by irRECIST)) with other clinical endpoints (e.g., OS, PFS, etc.) was performed.

Outcome measures

Outcome data not reported

Adverse Events

Arm A : Pembrolizumab + External Beam Radiation Therapy

Serious events: 7 serious events

Other events: 14 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 participants at risk Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Musculoskeletal and connective tissue disorders FLANK PAIN	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Renal and urinary disorders HEMATURIA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Metabolism and nutrition disorders HYPERGLYCEMIA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Respiratory, thoracic and mediastinal disorders HYPOXIA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Infections and infestations LUNG INFECTION	14.3% 2/14 • Number of events 3 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Infections and infestations SEPSIS	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Injury, poisoning and procedural complications SPINAL FRACTURE	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Vascular disorders THROMBOEMBOLIC EVENT	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOR PAIN	7.1% 1/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Vascular disorders VASCULAR DISORDERS	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.

Other adverse events

Other adverse events
Measure	Arm A : Pembrolizumab + External Beam Radiation Therapy n=14 participants at risk Pembrolizumab + External Beam Radiation Therapy Pembrolizumab: 200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered. External Beam Radiation Therapy: 20-30 Gy over five fractions for up to two cycles.
Gastrointestinal disorders ABDOMINAL PAIN	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations ALANINE AMINOTRANSFERASE INCREASED	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations ALKALINE PHOSPHATASE INCREASED	35.7% 5/14 • Number of events 5 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Blood and lymphatic system disorders ANEMIA	42.9% 6/14 • Number of events 9 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Metabolism and nutrition disorders ANOREXIA	28.6% 4/14 • Number of events 5 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Psychiatric disorders ANXIETY	21.4% 3/14 • Number of events 4 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Musculoskeletal and connective tissue disorders ARTHRITIS	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders ASCITES	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Musculoskeletal and connective tissue disorders BACK PAIN	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders BLOATING	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS	14.3% 2/14 • Number of events 5 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations BLOOD BILIRUBIN INCREASED	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders CONSTIPATION	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Respiratory, thoracic and mediastinal disorders COUGH	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations CREATININE INCREASED	21.4% 3/14 • Number of events 3 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Metabolism and nutrition disorders DEHYDRATION	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders DENTAL CARIES	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders DIARRHEA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Nervous system disorders DYSGEUSIA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Respiratory, thoracic and mediastinal disorders DYSPNEA	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
General disorders EDEMA LIMBS	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
General disorders FATIGUE	28.6% 4/14 • Number of events 5 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
General disorders FEVER	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Musculoskeletal and connective tissue disorders FLANK PAIN	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Nervous system disorders HEADACHE	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders HEMORRHOIDAL HEMORRHAGE	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Metabolism and nutrition disorders HYPERGLYCEMIA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Metabolism and nutrition disorders HYPERKALEMIA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Vascular disorders HYPERTENSION	21.4% 3/14 • Number of events 4 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Endocrine disorders HYPERTHYROIDISM	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Metabolism and nutrition disorders HYPOALBUMINEMIA	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Metabolism and nutrition disorders HYPOCALCEMIA	21.4% 3/14 • Number of events 5 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Metabolism and nutrition disorders HYPONATREMIA	21.4% 3/14 • Number of events 4 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Endocrine disorders HYPOTHYROIDISM	21.4% 3/14 • Number of events 4 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Respiratory, thoracic and mediastinal disorders HYPOXIA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations INVESTIGATIONS	14.3% 2/14 • Number of events 8 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations LYMPHOCYTE COUNT DECREASED	42.9% 6/14 • Number of events 10 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Musculoskeletal and connective tissue disorders MYALGIA	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders NAUSEA	28.6% 4/14 • Number of events 6 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Musculoskeletal and connective tissue disorders NECK PAIN	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations PLATELET COUNT DECREASED	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Renal and urinary disorders RENAL AND URINARY DISORDERS	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Cardiac disorders SINUS TACHYCARDIA	7.1% 1/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES	7.1% 1/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOR PAIN	42.9% 6/14 • Number of events 8 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Renal and urinary disorders URINARY FREQUENCY	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Gastrointestinal disorders VOMITING	7.1% 1/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations WEIGHT GAIN	7.1% 1/14 • Number of events 1 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations WEIGHT LOSS	35.7% 5/14 • Number of events 7 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.
Investigations WHITE BLOOD CELL DECREASED	14.3% 2/14 • Number of events 2 • From Cycle 1, Day 1 (each cycle is 21 days) visit up to a maximum of 19 months. Adverse events were collected for every subject at every cycle of treatment at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab. Serious AE (SAE) at any visit will continue to be followed until the AE resolves to ≤ Grade 1 or baseline, deemed clinically insignificant, and/or until a new anti-cancer treatment starts, whichever is earlier.

Additional Information

Annesha Majumdar

Hoosier Cancer Research Network

Phone: 3179212050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place