Trial Outcomes & Findings for Ph II Study of Cabozantinib With Pembrolizumab in Metastatic Gastric and Gastroesophageal Adenocarcinoma (NCT NCT04164979)

Last Updated: 2025-08-11

Results Overview

This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined death, radiographic progression or clinical deterioration attributed disease progression as judged by an investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm and/or appearance of new lesions.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

6 Months

Results posted on

2025-08-11

Participant Flow

Of 34 enrolled patients, 27 met inclusion criteria and were treated.

Participant milestones

Participant milestones
Measure	Cabozantinib and Pembrolizumab Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days. Cabozantinib: Given PO Pembrolizumab: Given IV
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ph II Study of Cabozantinib With Pembrolizumab in Metastatic Gastric and Gastroesophageal Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabozantinib and Pembrolizumab n=27 Participants Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days. Cabozantinib: Given PO Pembrolizumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Cabozantinib and Pembrolizumab n=27 Participants Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days. Cabozantinib: Given PO Pembrolizumab: Given IV
Percentage of Participants With Progression-free Survival at 6 Months	6 Participants

SECONDARY outcome

Timeframe: From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

To evaluate the tolerability of administering cabozantinib in combination with pembrolizumab in patients with advanced gastric and gastroesophageal adenocarcinoma from the start of treatment, duration of treatment and up to 4 weeks after completion of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

Outcome measures

Outcome measures
Measure	Cabozantinib and Pembrolizumab n=27 Participants Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days. Cabozantinib: Given PO Pembrolizumab: Given IV
Number of Participants Who Experienced Any Grade 3-5 Adverse Events	3 Participants

SECONDARY outcome

Timeframe: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.]

To assess the overall response rate to the combination of cabozantinib and pembrolizumab. Overall response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR

Outcome measures

Outcome measures
Measure	Cabozantinib and Pembrolizumab n=27 Participants Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days. Cabozantinib: Given PO Pembrolizumab: Given IV
Overall Response Rate as Assessed by RECIST v1.1	1 Participants

SECONDARY outcome

Timeframe: From date of registration until death from any cause, whichever came first.

To evaluate overall survival in patients with advanced gastric and gastroesophageal adenocarcinoma treated with this combination of cabozantinib and pembrolizumab.

Outcome measures

Outcome measures
Measure	Cabozantinib and Pembrolizumab n=27 Participants Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days. Cabozantinib: Given PO Pembrolizumab: Given IV
Overall Survival of Patients Who Received Cabozantinib and Pembrolizumab	5.5 months Interval 3.1 to 14.0

Adverse Events

Cabozantinib and Pembrolizumab

Serious events: 3 serious events

Other events: 27 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Cabozantinib and Pembrolizumab n=27 participants at risk Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days. Cabozantinib: Given PO Pembrolizumab: Given IV
Vascular disorders Hypertension	3.7% 1/27 • 4 years, 2 months
Blood and lymphatic system disorders Thromboembolic Event	3.7% 1/27 • 4 years, 2 months
Gastrointestinal disorders Esophageal Perforation	3.7% 1/27 • 4 years, 2 months

Other adverse events

Other adverse events
Measure	Cabozantinib and Pembrolizumab n=27 participants at risk Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days. Cabozantinib: Given PO Pembrolizumab: Given IV
Gastrointestinal disorders Diarrhea	14.8% 4/27 • 4 years, 2 months
General disorders Fatigue	18.5% 5/27 • 4 years, 2 months
Nervous system disorders Dysgeusia	7.4% 2/27 • 4 years, 2 months
Musculoskeletal and connective tissue disorders Muscle Cramps	7.4% 2/27 • 4 years, 2 months
Gastrointestinal disorders Mucositis	7.4% 2/27 • 4 years, 2 months
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	7.4% 2/27 • 4 years, 2 months
Endocrine disorders Hypothyroidism	11.1% 3/27 • 4 years, 2 months
Gastrointestinal disorders Abdominal Distension	7.4% 2/27 • 4 years, 2 months
Metabolism and nutrition disorders Anorexia	18.5% 5/27 • 4 years, 2 months
Vascular disorders Hypertension	11.1% 3/27 • 4 years, 2 months

Additional Information

Chao Family Comprehensive Cancer Center, University of California, Irvine

Phone: 1-877-UC-STUDY

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place