Trial · NCT03658772
Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer
NCT03658772, Phase 1, Completed, Arrys Therapeutics
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer. Trials, record NCT03658772. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03658772
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer
- NCT number
- NCT03658772
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 54 participants, actual
- Lead sponsor
- Arrys Therapeutics
- Conditions
- Microsatellite Stable Colorectal Cancer
- Interventions
- grapiprant, grapiprant and pembrolizumab
- First posted
- 2018-09-05
- Last updated
- 2023-10-24
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of grapiprant alone and in combination with pembrolizumab | Up to 90 days after the end of treatment (average of 7 months) | Number of incidence, severity, and duration of treatment emergent adverse events using CTCAE v5.0 |
| Primary | Define the recommended phase 2 dose (RP2D) of grapiprant combined with pembrolizumab | Through Cycle 1 (21 days) | Number, incidence and severity of treatment related adverse events as assessed by CTCAE 5.0 |
| Secondary | Overall Response Rate (ORR) | 7 months | Proportion of participants who achieved PR or better during the study per RECIST 1.1 |
| Secondary | Duration of Response (DOR) | 7 months | Time when criteria for response are met, to the first documentation of relapse or progression |
| Secondary | Progression -free survival (PFS) | Up to 12 months | Participants who discontinue treatment without disease progression |
| Secondary | Disease control rate (DCR) | 7 months | Percentage of participants who achieved a CR, PR and stable disease |
| Secondary | Overall survival (OS) | Up to 2 years from start of study drug. | Date of study drug to date of death due to any cause. If no documentation of death at time of the analysis will be censored as of the date last known to be alive, or the data cutoff date, whichever is earlier. |
| Secondary | Duration of treatment (DOT) | 7 months | Time of duration on treatment |
| Secondary | Serum tumor marker changes | 7 months | Assess changes in serum tumor markers including but not limited to carcinoembryonic antigen (CEA), when appropriate (eg. CA-19.9, CA125, and lactate dehyrogenase (LDH)) with disease response. |
| Secondary | Pharmacodynamic immune effects in paired tumor biopsies | predose through cycle 3 (each cycle is 21 days) | Assess changes in tumor infiltrating helper T cells, cytotoxic T cells and regulatory monocyte/macrophages with study drug treatment |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34606846 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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.
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/NCT03658772
GET https://conductscience.org/api/trials/v1/NCT03658772/registered