Trial Outcomes & Findings for Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma (NCT NCT03957551)

Last Updated: 2026-01-29

Results Overview

All adverse events (AEs) will be considered in DLT assessment unless an event is clearly unrelated to trial treatment. The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 will be used.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2026-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I: Cabozantinib and Pembrolizumab (40mg) Cabozantinib will be administered in the tablet form, at 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) Cabozantinib will be administered in the tablet form, at 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase II: Cabozantinib and Pembrolizumab (40 mg) Cabozantinib will be administered in the tablet form at the Recommended Phase 2 dose (RP2D), 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Overall Study STARTED	6	2	20
Overall Study COMPLETED	1	0	2
Overall Study NOT COMPLETED	5	2	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: Cabozantinib and Pembrolizumab (40mg) Cabozantinib will be administered in the tablet form, at 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) Cabozantinib will be administered in the tablet form, at 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase II: Cabozantinib and Pembrolizumab (40 mg) Cabozantinib will be administered in the tablet form at the Recommended Phase 2 dose (RP2D), 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Overall Study Adverse Event	2	2	6
Overall Study Physician Decision	1	0	2
Overall Study Withdrawal by Subject	1	0	2
Overall Study Disease progression	1	0	8

Baseline Characteristics

Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase II: Cabozantinib and Pembrolizumab n=20 Participants Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Total n=28 Participants Total of all reporting groups	Phase I: Cabozantinib and Pembrolizumab (40mg) n=6 Participants Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) n=2 Participants Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Age, Categorical <=18 years	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=8687 Participants	20 Participants n=153 Participants	4 Participants n=35 Participants	2 Participants n=4328 Participants
Age, Categorical >=65 years	6 Participants n=8687 Participants	8 Participants n=153 Participants	2 Participants n=35 Participants	0 Participants n=4328 Participants
Age, Continuous	54 years n=8687 Participants	56 years n=153 Participants	62 years n=35 Participants	54 years n=4328 Participants
Sex: Female, Male Female	6 Participants n=8687 Participants	12 Participants n=153 Participants	4 Participants n=35 Participants	2 Participants n=4328 Participants
Sex: Female, Male Male	14 Participants n=8687 Participants	16 Participants n=153 Participants	2 Participants n=35 Participants	0 Participants n=4328 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=8687 Participants	28 Participants n=153 Participants	6 Participants n=35 Participants	2 Participants n=4328 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Race (NIH/OMB) Asian	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Race (NIH/OMB) White	20 Participants n=8687 Participants	28 Participants n=153 Participants	6 Participants n=35 Participants	2 Participants n=4328 Participants
Race (NIH/OMB) More than one race	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=35 Participants	0 Participants n=4328 Participants
Region of Enrollment United States	20 participants n=8687 Participants	28 participants n=153 Participants	6 participants n=35 Participants	2 participants n=4328 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: Number of participants enrolled to Phase I cohorts (6 at 40mg and 2 at 60 mg levels)

Outcome measures

Outcome measures
Measure	Phase I: Cabozantinib and Pembrolizumab (40mg) n=6 Participants Cabozantinib will be administered in the tablet form, at 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) n=2 Participants Cabozantinib will be administered in the tablet form at 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Phase I: Number of Participants With a Dose Limiting Toxicity (DLT) Using CTCAE, Version 4.03	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Initiation of treatment up to 2 years

Population: Efficacy endpoints (e.g. ORR) were prespecified only for participants enrolled in Phase II.

The overall response rate (ORR) is the percentage of patients with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). A complete response (CR) is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm, and partial response (PR) is a \>=30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	Phase I: Cabozantinib and Pembrolizumab (40mg) n=20 Participants Cabozantinib will be administered in the tablet form, at 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) Cabozantinib will be administered in the tablet form at 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Phase II: Overall Response Rate	9 Participants	—

SECONDARY outcome

Timeframe: Initiation of treatment up to 2 years

Population: Efficacy endpoints (e.g. DCR) were prespecified only for participants enrolled in Phase II.

The disease control rate (DCR) is the percentage of patients with a complete response (CR), partial response (PR) or stable disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). A complete response (CR) is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm, partial response (PR) is a \>=30% decrease in the sum of the longest diameter of target lesions, and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

Outcome measures

Outcome measures
Measure	Phase I: Cabozantinib and Pembrolizumab (40mg) n=20 Participants Cabozantinib will be administered in the tablet form, at 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) Cabozantinib will be administered in the tablet form at 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Disease Control Rate	15 Participants	—

SECONDARY outcome

Timeframe: Initiation of treatment up to 2 years

Population: Efficacy endpoints (e.g. PFS) were prespecified only for participants enrolled in Phase II.

Progression-free survival (PFS) is defined as the time from study treatment initiation to the date of first documentation of disease progression or death due to any cause. Otherwise, patients were censored at date of last radiographic assessment.

Outcome measures

Outcome measures
Measure	Phase I: Cabozantinib and Pembrolizumab (40mg) n=20 Participants Cabozantinib will be administered in the tablet form, at 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) Cabozantinib will be administered in the tablet form at 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Progression-Free Survival	6.6 months Interval 2.9 to 29.5	—

SECONDARY outcome

Timeframe: Initiation of treatment up to 2 years

Population: Efficacy endpoints (e.g. OS) were prespecified only for participants enrolled in Phase II.

Overall survival (OS) is defined as the time from study treatment initiation to death due to any cause. Patients still alive were censored at the last date known to be alive. Cumulative OS was descriptively summarized over time with the Kaplan-Meier method. The landmark estimate at 2 years and associated 95% confidence interval is reported.

Outcome measures

Outcome measures
Measure	Phase I: Cabozantinib and Pembrolizumab (40mg) n=20 Participants Cabozantinib will be administered in the tablet form, at 40 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 40 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) Cabozantinib will be administered in the tablet form at 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form at 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Overall Survival at 2 Years	63 Percent Probability of Survival Interval 37.0 to 80.0	—

Adverse Events

Phase I: Cabozantinib and Pembrolizumab (40mg)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 2 deaths

Phase I: Cabozantinib and Pembrolizumab (60mg)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Phase II: Cabozantinib and Pembrolizumab (40mg)

Serious events: 7 serious events

Other events: 20 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: Cabozantinib and Pembrolizumab (40mg) n=6 participants at risk Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase I: Cabozantinib and Pembrolizumab (60mg) n=2 participants at risk Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.	Phase II: Cabozantinib and Pembrolizumab (40mg) n=20 participants at risk Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Cabozantinib: Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Pembrolizumab: Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
Cardiac disorders Myocarditis	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Gastrointestinal disorders Vomiting	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	50.0% 1/2 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/20 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
General disorders and administration site conditions Death NOS	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
General disorders and administration site conditions Pain	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Investigations Blood bilirubin increased	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Vascular disorders Hypertension	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Vascular disorders Hypotension	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/6 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	0.00% 0/2 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.	5.0% 1/20 • Number of events 1 • AEs were collected from the time of signing informed consent through 30 days after the last dose of cabozantinib and/or pembrolizumab treatment, up to 2 years.

Other adverse events

Additional Information

John Rieth, MD

University of Iowa

Phone: (319) 356-1616

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place