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Monoclonal Antibodies

Pembrolizumab + Capecitabine + Bevacizumab for Colorectal Cancer

Phase 2
Waitlist Available
Led By Chloe Atreya, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable disease or progression on a prior regimen containing infusional 5-FU or capecitabine
18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is studying capecitabine, pembrolizumab, and bevacizumab to see how well they work in treating patients with colorectal cancer that has spread to nearby tissues or lymph nodes, has spread to other places in the body, or that cannot be removed by surgery.

Who is the study for?
Adults with advanced colorectal cancer that's spread or can't be surgically removed, and is microsatellite stable (MSS) or mismatch repair proficient (pMMR). Participants must have had stable disease or progression after treatment with certain chemotherapy drugs. They should have good organ function, not be pregnant, agree to use contraception, and provide a recent tumor tissue sample if possible.Check my eligibility
What is being tested?
The trial tests the combination of pembrolizumab (an immune therapy), capecitabine (a chemotherapy drug), and bevacizumab (a drug that blocks blood vessel growth in tumors) for effectiveness and safety in treating colorectal cancer. It aims to find the best dose of capecitabine when used with the other two drugs.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells, bleeding issues due to blood vessel blockage by bevacizumab, typical chemotherapy-related symptoms like nausea from capecitabine, fatigue, increased risk of infections, and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition didn't improve or worsened after treatment with 5-FU or capecitabine.
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I am at least 18 years old.
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I can provide a recent biopsy sample or an older one with approval, and I am mostly active.
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My colorectal cancer is advanced and cannot be removed by surgery.
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My colorectal cancer is not highly mutated (MSS) or has normal mismatch repair proteins (pMMR).
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I am fully active or restricted in physically strenuous activity but can do light work.
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My colorectal cancer is not microsatellite instability-high (MSI-H).
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My cancer did not improve or worsened after treatment with 5-FU or capecitabine.
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I am at least 18 years old.
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My hemoglobin level is stable without needing transfusions or EPO.
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My colorectal cancer is advanced and cannot be surgically removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of treatment-related, dose-limiting toxicities (DLT) (Safety Lead-In Cohort)
Heart rate
Secondary outcome measures
Disease control rate (DCR) (Expansion Cohort)
Duration of response (DOR) (Expansion Cohort)
Overall survival (OS) (Expansion Cohort)
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, bevacizumab, capecitabine)Experimental Treatment4 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Pembrolizumab
2017
Completed Phase 2
~1950
Capecitabine
2013
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,491 Previous Clinical Trials
11,930,536 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,861 Previous Clinical Trials
5,049,010 Total Patients Enrolled
Chloe Atreya, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03396926 — Phase 2
Colorectal Cancer Research Study Groups: Treatment (pembrolizumab, bevacizumab, capecitabine)
Colorectal Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03396926 — Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03396926 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab obtained authorization from the FDA?

"Clinical evidence suggests that pembrolizumab has a relative safety rating of 2, as it is currently in the second phase trial and there are no current reports suggesting its efficacy."

Answered by AI

Are researchers recruiting for this experiment at the present moment?

"Unfortunately, no new candidates are being accepted as of now. This clinical trial was first posted on April 18th 2018 and its last update occurred on May 16th 2022. If you're still in search of other studies, 860 trials related to colorectal carcinoma and 1571 trials involving Pembrolizumab are actively recruiting participants."

Answered by AI

For what therapeutic applications is pembrolizumab regularly employed?

"Pembrolizumab can be a viable treatment option for individuals suffering from malignant neoplasms, unresectable melanoma, and cases of microsatellite instability high."

Answered by AI

What are the desired outcomes of this research?

"This clinical trial, expected to last up to 4 years, seeks to assess the frequency of treatment-related dose-limiting toxicities (DLT). Secondary goals include evaluating disease control rate (DCR) with exact binomial methods proposed by Clopper and Pearson (1934), progression-free survival (PFS) through Kaplan-Meier curves, as well as overall survival rates."

Answered by AI

Has Pembrolizumab been examined in any other research projects?

"At the moment, a grand total of 1571 medical studies have been initiated to investigate Pembrolizumab. Of these active trials, 318 are in their concluding Phase 3. Although most investigations into this treatment take place in Guangzhou, Guangdong, there are over 61 thousand sites worldwide testing it."

Answered by AI

Are there any limits to the number of individuals enrolled in this experiment?

"This study is not currently accepting patients. It was first posted on April 18th 2018 and last updated on May 16th 2022. If you are seeking alternative trials, 860 studies involving colorectal carcinoma have vacancies and 1571 Pembrolizumab-based experiments are actively recruiting participants."

Answered by AI
~6 spots leftby Mar 2025