Trial · NCT03519412
Pembrolizumab in MMR-Proficient Metastatic Colorectal Cancer Pharmacologically Primed to Trigger Hypermutation Status
NCT03519412, Phase 2, Completed, IFOM ETS - The AIRC Institute of Molecular Oncology; results first posted 2026-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab in MMR-Proficient Metastatic Colorectal Cancer Pharmacologically Primed to Trigger Hypermutation Status. Trials, record NCT03519412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03519412
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab in MMR-Proficient Metastatic Colorectal Cancer Pharmacologically Primed to Trigger Hypermutation Status
- NCT number
- NCT03519412
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular Oncology
- Conditions
- Colorectal Neoplasms, Microsatellite Instability
- Interventions
- temozolomide (induction),, pembrolizumab (treatment)
- First posted
- 2018-05-09
- Last updated
- 2026-03-03
- Other registries' IDs
- eudract:2018-001441-14
- Results first posted
- 2026-03-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Tumor assessments every 8-9 weeks from date of enrollment (in Trial Phase of the study) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. | Overall response rate (ORR) to pembrolizumab according to RECIST v1.1. An objective response is defined as either a CR or PR assessed by RECIST v1.1 at the discretion of the local investigator. |
| Secondary | Overall Response Rate (ORR) | Tumor assessments every 8-9 weeks from date of enrollment (in Trial Phase of the study) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. | Overall response rate (ORR) to pembrolizumab according to RECIST v1.1. An objective response is defined as either a CR or PR assessed by RECIST v1.1 criteria at the discretion of the local investigator. |
| Secondary | Progression Free Survival (PFS) | From the date of treatment initiation with pembrolizumab to the date of first documented progression or date of death from any cause, whichever came first, up to maximum 72 months. | Progression Free Survival (PFS) in pembrolizumab treated patients. PFS was estimated using the Kaplan-Meier method. Patient without disease progression were censored at the last follow-up visit available. |
| Secondary | Overall Survival (OS) | Every 8-12 weeks from date of treatment initiation with pembrolizumab to the date of death due to any cause (up to maximum 72 months). A participant who has not died will be censored at last known date alive. | Overall Survival (OS) in pembrolizumab treated patients. OS was estimated using the Kaplan-Meier method. Patient without disease progression were censored at the last survival follow-up available. |
| Secondary | Safety and Tolerability | From the time the first dose of study medication (either pembrolizumab or temozolomide) is administered until 30 days following discontinuation of study treatment. | Safety and Tolerability according to CTCAE version 4.03 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Tumor assessments every 8-9 weeks from date of enrollment (in Trial Phase of the study) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. | % of participants | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) | Tumor assessments every 8-9 weeks from date of enrollment (in Trial Phase of the study) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. | % of participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | From the date of treatment initiation with pembrolizumab to the date of first documented progression or date of death from any cause, whichever came first, up to maximum 72 months. | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Every 8-12 weeks from date of treatment initiation with pembrolizumab to the date of death due to any cause (up to maximum 72 months). A participant who has not died will be censored at last known date alive. | Months | MEDIAN | |
| SECONDARY | Safety and Tolerability | From the time the first dose of study medication (either pembrolizumab or temozolomide) is administered until 30 days following discontinuation of study treatment. | The Safety Evaluable (SE) population defined as all treated patients within ARETHUSA trial (i.e. eligible as decided at the time of registration that receives at least 1 dose of any study treatment temozolomide or Pembrolizumab). | Number or patients | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | TMZ-primed MMR-proficient (MMRp) | 0 | 95% Confidence Interval 0 to 0 | % of participants | |
| Overall Response Rate (ORR) | MMR-deficient (MMRd) | 54.3 | 95% Confidence Interval 32.7 to 84.8 | % of participants | |
| Progression Free Survival (PFS) | TMZ-primed MMR-proficient (MMRp) | 3.3 | 95% Confidence Interval 2.2 to 6.4 | Months | |
| Progression Free Survival (PFS) | MMR-deficient (MMRd) | 49.7 | 95% Confidence Interval 3.5 to NA | Months | |
| Overall Survival (OS) | TMZ-primed MMR-proficient (MMRp) | 5.6 | 95% Confidence Interval 2.9 to NA | Months | |
| Overall Survival (OS) | MMR-deficient (MMRd) | NA | 95% Confidence Interval 15.4 to NA | Months | |
| Safety and Tolerability | MMR-proficient (MMRp) | All treatment-related Adverse Event (AE), any grade | 42 | Number or patients | |
| Safety and Tolerability | MMR-deficient (MMRd)/TMZ-primed MMR-proficient (MMRp) | All treatment-related Adverse Event (AE), any grade | 15 | Number or patients | |
| Safety and Tolerability | MMR-proficient (MMRp) | All treatment-related Adverse Event (AE), grade ≥ 3 | 8 | Number or patients | |
| Safety and Tolerability | MMR-deficient (MMRd)/TMZ-primed MMR-proficient (MMRp) | All treatment-related Adverse Event (AE), grade ≥ 3 | 5 | Number or patients |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Priming Phase - Temozolomide treatment | STARTED | MMR-proficient (MMRp) | 72 | |
| Priming Phase - Temozolomide treatment | STARTED | MMR-deficient (MMRd) | 0 | |
| Priming Phase - Temozolomide treatment | STARTED | TMZ-primed MMR-proficient (MMRp): 22 | 0 | |
| Priming Phase - Temozolomide treatment | COMPLETED | MMR-proficient (MMRp) | 72 | |
| Priming Phase - Temozolomide treatment | COMPLETED | MMR-deficient (MMRd) | 0 | |
| Priming Phase - Temozolomide treatment | COMPLETED | TMZ-primed MMR-proficient (MMRp): 22 | 0 | |
| Priming Phase - Temozolomide treatment | NOT COMPLETED | MMR-proficient (MMRp) | 0 | |
| Priming Phase - Temozolomide treatment | NOT COMPLETED | MMR-deficient (MMRd) | 0 | |
| Priming Phase - Temozolomide treatment | NOT COMPLETED | TMZ-primed MMR-proficient (MMRp): 22 | 0 | |
| Trial Phase - Pembrolizumab treatment | STARTED | MMR-proficient (MMRp) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | MMR-proficient (MMRp) | 2 | 66 | |
| other | Anaemia | Blood and lymphatic system disorders | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 8 | 57 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MMR-proficient (MMRp) | 6 | 66 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 0 | 57 | |
| other | Nausea | Gastrointestinal disorders | MMR-proficient (MMRp) | 18 | 66 | |
| other | Nausea | Gastrointestinal disorders | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 3 | 57 | |
| other | Neutropenia | Blood and lymphatic system disorders | MMR-proficient (MMRp) | 6 | 66 | |
| other | Neutropenia | Blood and lymphatic system disorders | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 0 | 57 | |
| other | Asthenia | General disorders | MMR-proficient (MMRp) | 3 | 66 | |
| other | Asthenia | General disorders | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 3 | 57 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MMR-proficient (MMRp) | 6 | 66 |
| Total, all-cause mortality | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 13 | 57 |
| Total, other adverse events | MMR-proficient (MMRp) | 30 | 66 |
| Total, other adverse events | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 14 | 57 |
| Total, serious adverse events | MMR-proficient (MMRp) | 14 | 66 |
| Total, serious adverse events | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 20 | 57 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MMR-proficient (MMRp) vs MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp): deaths from any cause | Trial comparisons |
| MMR-proficient (MMRp) vs MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp): serious adverse events | Trial comparisons |
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/NCT03519412
GET https://conductscience.org/api/trials/v1/NCT03519412/events?page=2