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Trial · NCT03657641

Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

NCT03657641, Phase 1, Phase 2, Active not recruiting, University of Southern California

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer. Trials, record NCT03657641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03657641

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer
NCT number
NCT03657641
Status
Active not recruiting
Phases
Phase 1, Phase 2
Enrollment
73 participants, actual
Lead sponsor
University of Southern California
Conditions
Colorectal Cancer, Colorectal Cancer Metastatic
Interventions
Pembrolizumab, Regorafenib
First posted
2018-09-05
Last updated
2026-06-16

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Patients With Dose Modification Due to ToxicityAt the end of Course 1 (each course is 21 days)
Number of patients that required a dose modification while on study treatment, due to a Dose limiting toxicity (DLT), during Phase I and Phase II. DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 and is defined in the study protocol section 6.2.
PrimaryProgression-free Survival (PFS) (Phase II)At first observation of disease progression or death whichever comes first, up to 3 years and 8 months.
PFS will be calculated from the start of treatment (day 1 of cycle 1) to the first observation of disease progression or death whichever comes first, or to the latest follow up. Kaplan Meier curves will be used for PFS plot. Medians of PFS and their 95% CI confidence intervals will be given.
PrimaryOverall Survival (OS)At last date known to be alive, up to 3 years and 8 months.OS will be calculated from the start of treatment (day 1 or cycle 1) to death from any cause. Kaplan Meier curves will be used to OS plot. Medians and their 95%CI confidence intervals will be given.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA014089University of Southern California Norris Comprehensive Cancer Center Support Grant (CCSG)LERMAN, CARYNUNIVERSITY OF SOUTHERN CALIFORNIANATIONAL CANCER INSTITUTE1985 to 2025

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03657641

GET https://conductscience.org/api/trials/v1/NCT03657641/registered