Trial Outcomes & Findings for 177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT03805594)

Last Updated: 2025-02-25

Results Overview

The Recommended Phase 2 Dosing Schedule (RP2DS) (Schedule 1: a single priming dose of 177Lu-PSMA-617 (7·4 giga-becquerel (GBq) \[200 millicurie (mCi)\] given 28 days before pembrolizumab; Schedule 2: a single priming dose of 177Lu-PSMA-617 given concomitant with pembrolizumab; or Schedule 3: a single priming dose of 177Lu-PSMA-617 given 21 days after the start of maintenance pembrolizumab (200 mg every 3 weeks)) will be determined from the safety data as classified by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for dose-limiting toxicities, aggregate safety data and feasibility of administration. The number of dose-limiting toxicities reported by participants in Part A used to determine the RP2DS for participants enrolling under Part B will be reported by arm.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

43 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2025-02-25

Participant Flow

In Part A, three dosing schedules of priming lutetium-177 (¹⁷⁷Lu)-PSMA-617 (vipivotide tetraxetan) were assessed. Dose expansion in phase 1b (Part B) was subsequently evaluated using the recommended phase 2 dosing schedule.

Participant milestones

Participant milestones
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Overall Study STARTED	6	6	6	25
Overall Study COMPLETED	6	6	6	25
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=25 Participants Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Total n=43 Participants Total of all reporting groups
Age, Customized 50-59 years old	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Age, Customized 60-69 years old	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Age, Customized 70-79 years old	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants	16 Participants n=21 Participants
Age, Customized 80-89 years old	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants
Age, Customized 90-99 years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants	43 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants	43 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants	34 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	25 participants n=4 Participants	43 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Schedule 1, a single priming dose of 177Lu-PSMA-617 given 28 days before pembrolizumab was determined to be the RP2DS for participants enrolled under Part B

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Number of Reported Dose Limiting Toxicities (DLT) (Part A Only)	0 dose-limiting toxicities	1 dose-limiting toxicities	1 dose-limiting toxicities	—

PRIMARY outcome

Timeframe: Up to 2 years

The ORR for participants in Part B is defined as the percentage of participants in Part B who obtained a confirmed diagnosis of complete response (CR) or partial response (PR), using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for the evaluation of radiographic CTs or MRIs performed during the course of the study to assess response. The ORR will be reported with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=25 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Objective Response Rate (ORR) (Part B Only)	56 percentage of participants Interval 35.0 to 76.0	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

The number of participants who reported adverse events defined by NCI CTCAE version 5.0 and attributed by the investigator to having been possibly, probably, or definitely related to study treatment will be reported.

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 Participants Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=25 Participants Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Number of Participants With Treatment-related Adverse Events	0 participants	1 participants	2 participants	9 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Per the pre-specified statistical analysis plan outlined in the study protocol, additional efficacy endpoints other than ORR including median duration of response was planned to be analyzed in the overall study cohort (n = 43). There was no pre-specified plan to analyze efficacy outcomes by study schedule (schedule 1, 2, 3). Post-hoc determination of efficacy outcomes for schedules 1,2, 3 analyzed separately is precluded by the limited sample size on schedules 2 and 3 (n = 6 each).

The median duration of response in months for all participants who received at least one dose of protocol therapy (i.e., one dose of pembrolizumab or 177Lu-PSMA-617) and who also demonstrated a confirmed response of complete response (CR) or partial response (PR) per RECIST criteria from the time of first response until confirmed disease progression, death or study completion will be reported.

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=43 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Median Duration of Response	8.1 months Interval 6.0 to 10.0	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: Per the pre-specified statistical analysis plan outlined in the study protocol, additional efficacy endpoints other than ORR including PSA50 was planned to be analyzed in the overall study cohort (n = 43). There was no pre-specified plan to analyze efficacy outcomes by study schedule (schedule 1, 2, 3). Post-hoc determination of efficacy outcomes for schedules 1,2, 3 analyzed separately is precluded by the limited sample size on schedules 2 and 3 (n = 6 each).

The percentage of all for all participants who received at least one dose of protocol therapy (i.e., one dose of pembrolizumab or 177Lu-PSMA-617) and who also achieved a greater than 50% decline from the time of the baseline PSA value obtained on cycle 1 day 1 (C1D1) at any point in the treatment course will be reported along with the 95% confidence interval.

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=43 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Prostate-specific Antigen (PSA) Response Rate (PSA50)	44 percentage of participants Interval 29.0 to 59.0	—	—	—

SECONDARY outcome

Timeframe: Up to 6 months

Population: Per the pre-specified statistical analysis plan outlined in the study protocol, additional efficacy endpoints other than ORR including rPFS at 6 months was planned to be analyzed in the overall study cohort (n = 43). There was no pre-specified plan to analyze efficacy outcomes by study schedule (schedule 1, 2, 3). Post-hoc determination of efficacy outcomes for schedules 1,2, 3 analyzed separately is precluded by the limited sample size on schedules 2 and 3 (n = 6 each).

rPFS is defined as the percentage all for all participants who received at least one dose of protocol therapy (i.e., one dose of pembrolizumab or 177Lu-PSMA-617) and who are still alive and progression-free per RECIST v1.1 and PCWG3 criteria at 6 months.

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=43 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Radiographic Progression-Free Survival Rate (rPFS) at 6 Months	51 percentage of participants Interval 35.0 to 67.0	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: Per the pre-specified statistical analysis plan outlined in the study protocol, additional efficacy endpoints other than ORR including Median PSA progression-free survival was planned to be analyzed in overall study cohort (n = 43). There was no pre-specified plan to analyze efficacy outcomes by study schedule (schedule 1, 2, 3). Post-hoc determination of efficacy outcomes for schedules 1,2, 3 analyzed separately is precluded by the limited sample size on schedules 2 and 3 (n = 6 each).

PSA progression-free survival for all participants who received at least one dose of protocol therapy (i.e., one dose of pembrolizumab or 177Lu-PSMA-617) will be defined using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria as the duration in months from date of first treatment to date the participant first meets the criteria for PSA progression for clinical progression, death, or study completion, whichever occurs first. The median duration and 95% confidence interval will be reported.

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=43 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Median PSA Progression-free Survival	6.9 months Interval 3.9 to 7.0	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: Per the pre-specified statistical analysis plan outlined in the study protocol, additional efficacy endpoints other than ORR including Median Overall Survival (OS) was planned to be analyzed in overall study cohort (n = 43). There was no pre-specified plan to analyze efficacy outcomes by study schedule (schedule 1, 2, 3). Post-hoc determination of efficacy outcomes for schedules 1,2, 3 analyzed separately is precluded by the limited sample size on schedules 2 and 3 (n = 6 each).

Median overall survival for all participants who received at least one dose of protocol therapy (i.e., one dose of pembrolizumab or 177Lu-PSMA-617) is defined as the number of months from the first date of therapy until date of death from any cause. The median number of months and 95% confidence interval will be estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=43 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Median Overall Survival (OS)	28.2 months Interval 20.4 to 40.0	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: Per the pre-specified statistical analysis plan outlined in the study protocol, additional efficacy endpoints other than ORR including median time to SSRE was planned to be analyzed in overall study cohort (n = 43). There was no pre-specified plan to analyze efficacy outcomes by study schedule (schedule 1, 2, 3). Post-hoc determination of efficacy outcomes for schedules 1, 2, 3 analyzed separately is precluded by the limited sample size on schedules 2 and 3 (n = 6 each).

Symptomatic skeletal related event is defined as the first occurrence of one or more of the following: symptomatic fracture, surgery or radiation to bone, or spinal cord compression. The median time in months to symptomatic skeletal related event for all participants who received at least one dose of protocol therapy (i.e., one dose of pembrolizumab or 177Lu-PSMA-617) will be reported with the 95% confidence interval.

Outcome measures

Outcome measures
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=43 Participants Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Median Time to Symptomatic Skeletal Related Event (SSRE)	24.7 months Interval 20.7 to There were insufficient number of events so the upper range of the confidence interval could not be calculated	—	—	—

Adverse Events

Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 4 deaths

Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab)

Serious events: 5 serious events

Other events: 24 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 participants at risk Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 participants at risk Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 participants at risk Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=25 participants at risk Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Infections and infestations Infections and infestations - Other	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Gastrointestinal disorders Ileus	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Infections and infestations Pneumonitis	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Renal and urinary disorders Renal and urinary disorders - Other	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Gastrointestinal disorders Gastric ulcer	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Cardiac disorders Ventricular tachycardia	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years

Other adverse events

Other adverse events
Measure	Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 participants at risk Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 participants at risk Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=6 participants at risk Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.	Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) n=25 participants at risk Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
General disorders Fatigue	33.3% 2/6 • Number of events 3 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	100.0% 6/6 • Number of events 10 • Up to 3 years	80.0% 20/25 • Number of events 25 • Up to 3 years
General disorders Pain	33.3% 2/6 • Number of events 2 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	50.0% 3/6 • Number of events 4 • Up to 3 years	20.0% 5/25 • Number of events 5 • Up to 3 years
General disorders Fever	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
General disorders Localized edema	16.7% 1/6 • Number of events 1 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
General disorders Non-cardiac chest pain	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 5 • Up to 3 years
General disorders Facial pain	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
General disorders Flu like symptoms	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 2 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Gastrointestinal disorders Nausea	33.3% 2/6 • Number of events 3 • Up to 3 years	33.3% 2/6 • Number of events 4 • Up to 3 years	66.7% 4/6 • Number of events 4 • Up to 3 years	40.0% 10/25 • Number of events 11 • Up to 3 years
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 3 • Up to 3 years	50.0% 3/6 • Number of events 4 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Number of events 2 • Up to 3 years	33.3% 2/6 • Number of events 2 • Up to 3 years	33.3% 2/6 • Number of events 2 • Up to 3 years	20.0% 5/25 • Number of events 6 • Up to 3 years
Gastrointestinal disorders Dry mouth	33.3% 2/6 • Number of events 2 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	24.0% 6/25 • Number of events 6 • Up to 3 years
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Gastrointestinal disorders Gastritis	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 2 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Gastrointestinal disorders Oral pain	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Musculoskeletal and connective tissue disorders Bone pain	33.3% 2/6 • Number of events 2 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	32.0% 8/25 • Number of events 9 • Up to 3 years
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	33.3% 2/6 • Number of events 4 • Up to 3 years	16.0% 4/25 • Number of events 4 • Up to 3 years
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 2 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 5 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Musculoskeletal and connective tissue disorders Muscle cramp	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Number of events 2 • Up to 3 years	33.3% 2/6 • Number of events 3 • Up to 3 years	50.0% 3/6 • Number of events 3 • Up to 3 years	24.0% 6/25 • Number of events 6 • Up to 3 years
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 2 • Up to 3 years	8.0% 2/25 • Number of events 5 • Up to 3 years
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • Up to 3 years	33.3% 2/6 • Number of events 2 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Investigations Weight loss	33.3% 2/6 • Number of events 2 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Investigations Creatinine increased	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	8.0% 2/25 • Number of events 3 • Up to 3 years
Investigations Alanine aminotransferase increased	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	4.0% 1/25 • Number of events 2 • Up to 3 years
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 3 • Up to 3 years
Investigations Neutrophil count decreased	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Nervous system disorders Dizziness	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Nervous system disorders Headache	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 3 • Up to 3 years
Nervous system disorders Cognitive disturbance	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Nervous system disorders Dysgeusia	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 2 • Up to 3 years	16.7% 1/6 • Number of events 2 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	16.0% 4/25 • Number of events 7 • Up to 3 years
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	12.0% 3/25 • Number of events 3 • Up to 3 years
Blood and lymphatic system disorders Anemia	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	16.0% 4/25 • Number of events 4 • Up to 3 years
Infections and infestations Upper respiratory infection	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Renal and urinary disorders Hematuria	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Eye disorders Dry eye	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	12.0% 3/25 • Number of events 3 • Up to 3 years
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Reproductive system and breast disorders Pelvic pain	16.7% 1/6 • Number of events 3 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Reproductive system and breast disorders Breast pain	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years
Vascular disorders Hot flashes	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	8.0% 2/25 • Number of events 2 • Up to 3 years
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	4.0% 1/25 • Number of events 1 • Up to 3 years
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	12.0% 3/25 • Number of events 4 • Up to 3 years
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/25 • Up to 3 years
Endocrine disorders Hypothyroidism	16.7% 1/6 • Number of events 1 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	20.0% 5/25 • Number of events 5 • Up to 3 years
Investigations Platelet count decreased	16.7% 1/6 • Number of events 2 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/6 • Up to 3 years	0.00% 0/25 • Up to 3 years

Additional Information

Dr. Rahul Aggarwal, MD

University of California, San Francisco

Phone: (415) 353-7171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place