18 and older, any sex, with Microsatellite Stable or Mismatch Repair Protein Proficient. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Participants With Treatment-related, Dose-limiting Toxicities (DLT) (Safety Lead-In Cohort)Primary· Up to 1 cycle (each cycle is 21 days)
A DLT evaluation of the first 6 participants will be conducted to confirm the safety of administering pembrolizumab at 200 mg (flat dosing) every three weeks with capecitabine and bevacizumab and include all participants in the safety lead in cohort who received at least 1 dose of study treatment. At least one laboratory or vital sign measurement obtained subsequent to at least one dose of study treatment is required for inclusion in the analysis including a baseline measure. Dose-limiting toxicity (DLT) must be clinically-significant toxicities which are at least possibly treatment-related pe
Group
Value
95% CI
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
0.33
Overall Response Rate (ORR)Primary· Up to 4 years
ORR is defined as the percentage of the participants in the ASaT population who have a confirmed complete response (CR) or a partial response (PR) (Overall Response (OR) = CR + PR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 on Computerized Tomography (CT) or magnetic resonance imaging or (MRI) imaging if a CT cannot be obtained. The ORR and 95% confidence interval will be provided using exact binomial method proposed by Clopper and Pearson (1934).
Group
Value
95% CI
ASaT Population (Pembrolizumab, Bevacizumab, Capecitabine)
5
0.6 – 16.9
Disease Control Rate (DCR)Secondary· Up to 4 years
DCR is defined as the percentage of participants who have achieved confirmed CR or PR or have demonstrated stable disease (SD) for at least 24 weeks prior to any evidence of progression assessed by RECIST and immune-related RECIST (irRECIST). The percentage of participants and 95% confidence interval, will be provided using exact binomial method proposed by Clopper and Pearson (1934).
Group
Value
95% CI
ASaT Population (Pembrolizumab, Bevacizumab, Capecitabine)
25
16.7 – 41.2
Median Duration of Response (DOR)Secondary· Up to 4 years
Duration of response is defined as the time from first documented evidence of CR or PR assessed by RECIST and irRECIST until disease progression or death due to any cause, whichever occurs first. Kaplan-Meier (KM) curves and median estimates from will be reported
Group
Value
95% CI
ASaT Population (Pembrolizumab, Bevacizumab, Capecitabine)
13.5
12.3 – NA
Median Overall Survival (OS)Secondary· Up to 4 years
OS is defined as the time from first day of study treatment to death due to any cause. Subjects without documented death at the time of the final analysis will be censored at the date of the last follow-up. KM curves and median estimates from the KM curves will be provided as appropriate.
Group
Value
95% CI
ASaT Population (Pembrolizumab, Bevacizumab, Capecitabine)
10.1
8.52 – 15.2
Median Progression-Free Survival (PFS)Secondary· Up to 4 years
PFS is defined as the time from first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Median estimates in months and the 95% confidence interval will be reported.
Group
Value
95% CI
ASaT Population (Pembrolizumab, Bevacizumab, Capecitabine)
4.29
3.68 – 6.05
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 4 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine)
This phase II trial studies the side effects and best dose of capecitabine when given together with pembrolizumab and bevacizumab, and investigates how well they work in treating patients with microsatellite stable 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. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine together with pembrolizumab and bevacizumab may work better in treating patients with colorectal cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07504588 — Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and
· Phase 2
· not yet recruiting
NCT07500298 — Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable
· Phase 1
· not yet recruiting
NCT07271355 — Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colore
· Phase 3
· not yet recruiting
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
· EARLY_PHASE1
· not yet recruiting
NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance
· Phase 2
· not yet recruiting
Other recruiting trials for Microsatellite Stable
Currently open trials in the same condition.
NCT03983993 — Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer
· Phase 2
· active not recruiting
Other University of California, San Francisco trials
Trials by the same sponsor.
NCT05284773 — Screening for Acute Malnutrition
· NA
· withdrawn
NCT04634851 — Video Home Visits for Dietary Counselling
· NA
· not yet recruiting
NCT06065670 — Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a M
· Phase 1, PHASE2
· not yet recruiting
NCT07534098 — Intervention for Hearing Health Among Native Americans
· NA
· not yet recruiting
NCT06960421 — Exercise-based Frailty Intervention in Lung Transplantation (XFIT)
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 28 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03396926.