Trial · NCT02834052
Pembrolizumab + Poly-ICLC in MRP Colon Cancer
NCT02834052, Phase 1, Phase 2, Completed, Asha Nayak; results first posted 2024-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab + Poly-ICLC in MRP Colon Cancer. Trials, record NCT02834052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02834052
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab + Poly-ICLC in MRP Colon Cancer
- NCT number
- NCT02834052
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Asha Nayak
- Conditions
- Metastatic Colon Cancer, Solid Tumor
- Interventions
- pembrolizumab, Poly-ICLC
- First posted
- 2016-07-15
- Last updated
- 2024-06-07
- Results first posted
- 2024-06-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Determine the Maximum Tolerated Dose of Poly-ICLC That Can be Combined With Pembrolizumab | 12 months | A minimum of 3 participants will be treated at dose level 1 (1mg). * If 0 out of 3 participants experience dose limiting toxicities (DLT), then dose escalation will proceed to dose level 2 (2mg). * If 1 out of 3 participants experience DLT, a cohort of additional 3 participants will be assigned to the same dose level (1mg). * If 2 or more participants of 3 (or 6) experience DLT at dose level 1, then enrollment of participants will be stopped. |
| Primary | Phase 1 and 2: Determine the Response Rate of Metastatic MRP Colon Cancer (That Has Progressed Following Two Lines of Therapy in the Metastatic Setting) to the Combination of Pembrolizumab and Poly-ICLC | From baseline to disease progression (Expected 12-24 months) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Primary | Determine the Overall Survival Rate for Recurrent Metastatic MRP Colon Cancer Response to the Combination of Pembrolizumab and Poly-ICLC | From baseline to disease progression (up to 24 months) | The overall survival rate of response to the combination of pembrolizumab and poly-ICLC administered at the Recommended Phase 2 Dose (RP2D) will be estimated along with the correspondent 95% confidence interval. |
| Secondary | Determine the Adverse Event Profile and Dose Limiting Toxicities of the Combination of Pembrolizumab and Poly-ICLC | 12 months | The adverse event profile will be presented by dose level of the combination treatment for the phase I portion |
| Secondary | Determine the 20-week Progression Free Survival Rate of Recurrent Metastatic MRP Colon Cancer to the Combination of Pembrolizumab and Poly-ICLC | 20 weeks | The 20-week progression free survival rate for the combination of pembrolizumab and poly-ICLC administered at the Recommended Phase 2 Dose (RP2D) will be estimated along with the correspondent 95% confidence interval. |
| Secondary | Determine the Duration of Response of Recurrent Metastatic MRP Colon Cancer to the Combination of Pembrolizumab and Poly-ICLC | From baseline to disease progression (up to 24 months) | The duration of response to the combination of pembrolizumab and poly-ICLC administered at the Recommended Phase 2 Dose (RP2D) will be estimated along with the correspondent 95% confidence interval. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Determine the Maximum Tolerated Dose of Poly-ICLC That Can be Combined With Pembrolizumab | 12 months | The safety population for this trial includes all participants who received at least one dose of the investigational product and excludes any participants who were screen fails. | mg | NUMBER |
| PRIMARY | Phase 1 and 2: Determine the Response Rate of Metastatic MRP Colon Cancer (That Has Progressed Following Two Lines of Therapy in the Metastatic Setting) to the Combination of Pembrolizumab and Poly-ICLC | From baseline to disease progression (Expected 12-24 months) | The analysis population is the number of patients who received treatment. The outcome measure population below is determined by the number of patients within each dataset (each cohort) with complete response (CR) or partial response (PR) defined by RECIST criteria. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Determine the Overall Survival Rate for Recurrent Metastatic MRP Colon Cancer Response to the Combination of Pembrolizumab and Poly-ICLC | From baseline to disease progression (up to 24 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Determine the Adverse Event Profile and Dose Limiting Toxicities of the Combination of Pembrolizumab and Poly-ICLC | 12 months | The percentage of participants that experienced severe adverse events. | percentage of participants | NUMBER |
| SECONDARY | Determine the 20-week Progression Free Survival Rate of Recurrent Metastatic MRP Colon Cancer to the Combination of Pembrolizumab and Poly-ICLC | 20 weeks | Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as any tumor enlargement greater than 20% and 5mm from baseline. The number of patients analyzed were the patients who received treatment. The outcome measure describes the count of patients who did not progress. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Determine the Duration of Response of Recurrent Metastatic MRP Colon Cancer to the Combination of Pembrolizumab and Poly-ICLC | From baseline to disease progression (up to 24 months) | Only one participant on this trial responded to the study treatment, so the 95% confidence interval could not be calculated. | weeks | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Determine the Maximum Tolerated Dose of Poly-ICLC That Can be Combined With Pembrolizumab | Phase 1: Poly-ICLC: 1 and 2 mg | 2 | mg | ||
Phase 1 and 2: Determine the Response Rate of Metastatic MRP Colon Cancer (That Has Progressed Following Two Lines of Therapy in the Metastatic Setting) to the Combination of Pembrolizumab and Poly-ICLC | Phase 1: Poly-ICLC: 1mg | 0 | Participants | ||
Phase 1 and 2: Determine the Response Rate of Metastatic MRP Colon Cancer (That Has Progressed Following Two Lines of Therapy in the Metastatic Setting) to the Combination of Pembrolizumab and Poly-ICLC | Phase 1: Poly-ICLC 2mg | 0 | Participants | ||
Phase 1 and 2: Determine the Response Rate of Metastatic MRP Colon Cancer (That Has Progressed Following Two Lines of Therapy in the Metastatic Setting) to the Combination of Pembrolizumab and Poly-ICLC | Phase 2: Poly-ICLC: 2mg | 1 | Participants | ||
| Determine the Overall Survival Rate for Recurrent Metastatic MRP Colon Cancer Response to the Combination of Pembrolizumab and Poly-ICLC | Phase 1: Poly-ICLC: 1mg | 0 | Participants | ||
| Determine the Overall Survival Rate for Recurrent Metastatic MRP Colon Cancer Response to the Combination of Pembrolizumab and Poly-ICLC | Phase 1: Poly-ICLC: 2mg | 0 | Participants | ||
| Determine the Overall Survival Rate for Recurrent Metastatic MRP Colon Cancer Response to the Combination of Pembrolizumab and Poly-ICLC | Phase 2: Poly-ICLC: 2mg | 0 | Participants | ||
| Determine the Adverse Event Profile and Dose Limiting Toxicities of the Combination of Pembrolizumab and Poly-ICLC | Phase 1: Poly-ICLC: 1mg | 87.5 | percentage of participants | ||
| Determine the Adverse Event Profile and Dose Limiting Toxicities of the Combination of Pembrolizumab and Poly-ICLC | Phase 1: Poly-ICLC 2mg | 70 | percentage of participants | ||
| Determine the Adverse Event Profile and Dose Limiting Toxicities of the Combination of Pembrolizumab and Poly-ICLC | Phase 2: Poly-ICLC: 2mg | 70.83 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: Poly-ICLC: 1mg | 8 | |
| Overall Study | STARTED | Phase 1: Poly-ICLC 2mg | 10 | |
| Overall Study | STARTED | Phase 2: Poly-ICLC: 2mg | 24 | |
| Overall Study | COMPLETED | Phase 1: Poly-ICLC: 1mg | 0 | |
| Overall Study | COMPLETED | Phase 1: Poly-ICLC 2mg | 0 | |
| Overall Study | COMPLETED | Phase 2: Poly-ICLC: 2mg | 0 | |
| Overall Study | NOT COMPLETED | Phase 1: Poly-ICLC: 1mg | 8 | |
| Overall Study | NOT COMPLETED | Phase 1: Poly-ICLC 2mg | 10 | |
| Overall Study | NOT COMPLETED | Phase 2: Poly-ICLC: 2mg | 24 |
Source ClinicalTrials.gov
Adverse events87
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 |
|---|---|---|---|---|---|---|
| serious | Abdominal Distention | Gastrointestinal disorders | Phase 1: Poly-ICLC: 1mg | 1 | 8 | 1 |
| serious | Abdominal Distention | Gastrointestinal disorders | Phase 1: Poly-ICLC: 2mg | 0 | 10 | 0 |
| serious | Abdominal Distention | Gastrointestinal disorders | Phase 2: Poly-ICLC: 2mg | 1 | 24 | 1 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Phase 1: Poly-ICLC: 1mg | 3 | 8 | 3 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Phase 1: Poly-ICLC: 2mg | 1 | 10 | 1 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Phase 2: Poly-ICLC: 2mg | 2 | 24 | 2 |
| serious | Small Bowel Obstruction | Gastrointestinal disorders | Phase 1: Poly-ICLC: 1mg | 1 | 8 | 1 |
| serious | Small Bowel Obstruction | Gastrointestinal disorders | Phase 1: Poly-ICLC: 2mg | 0 | 10 | 0 |
| serious | Small Bowel Obstruction | Gastrointestinal disorders | Phase 2: Poly-ICLC: 2mg | 0 | 24 | 0 |
| serious | Leukocytosis | Blood and lymphatic system disorders | Phase 1: Poly-ICLC: 1mg | 0 | 8 | 0 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Poly-ICLC: 1mg | 8 | 8 |
| Total, all-cause mortality | Phase 1: Poly-ICLC: 2mg | 10 | 10 |
| Total, all-cause mortality | Phase 2: Poly-ICLC: 2mg | 23 | 24 |
| Total, other adverse events | Phase 1: Poly-ICLC: 1mg | 0 | 8 |
| Total, other adverse events | Phase 1: Poly-ICLC: 2mg | 0 | 10 |
| Total, other adverse events | Phase 2: Poly-ICLC: 2mg | 0 | 24 |
| Total, serious adverse events | Phase 1: Poly-ICLC: 1mg | 7 | 8 |
| Total, serious adverse events | Phase 1: Poly-ICLC: 2mg | 7 | 10 |
| Total, serious adverse events | Phase 2: Poly-ICLC: 2mg | 17 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02834052
GET https://conductscience.org/api/trials/v1/NCT02834052/events?page=2