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Checkpoint Inhibitor

pembrolizumab for Colon Cancer

Phase 1 & 2
Waitlist Available
Led By Asha Nayak, MD
Research Sponsored by Asha Nayak
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to disease progression (expected 12-24 months)
Awards & highlights

Study Summary

This trial is testing a new combination therapy for colon cancer patients who are unlikely to respond to pembrolizumab alone. The goal is to find a safe dose of poly-ICLC and to evaluate how well it activates the immune system.

Eligible Conditions
  • Colon Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to disease progression (expected 12-24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to disease progression (expected 12-24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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: Determine the maximum tolerated dose of poly-ICLC that can be combined with pembrolizumab
Secondary outcome measures
Determine the 20-week progression free survival rate of recurrent metastatic MRP colon cancer to the combination of pembrolizumab and poly-ICLC
Determine the adverse event profile and dose limiting toxicities of the combination of pembrolizumab and poly-ICLC
Determine the duration of response of recurrent metastatic MRP colon cancer to the combination of pembrolizumab and poly-ICLC
+2 more

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894
12%
Weight decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Decreased appetite
9%
Arthralgia
9%
Constipation
9%
Haemoptysis
9%
Diarrhoea
9%
Hypothyroidism
9%
Nasopharyngitis
9%
Bronchitis
6%
Cough
6%
Asthenia
6%
Pruritus
6%
Anaemia
6%
Pneumonia
6%
Headache
6%
Blood alkaline phosphatase increased
3%
Malaise
3%
Hyperglycaemia
3%
Pneumonia bacterial
3%
White blood cell count decreased
3%
Back pain
3%
Myalgia
3%
Hypertension
3%
Pyrexia
3%
Hyperthyroidism
3%
Upper respiratory tract infection
3%
Nausea
3%
Dyspnoea
3%
Leukopenia
3%
Chest pain
3%
Rash
3%
Subdural haemorrhage
3%
Lymph gland infection
3%
Tumour associated fever
3%
Haematemesis
3%
Upper gastrointestinal haemorrhage
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment2 Interventions
In Phase 2, all participants will receive the standard pembrolizumab dose (200 mg IV q3w) in addition to the maximum tolerated dose of poly-ICLC (either 1 mg or 2 mg), as determined by the Phase 1 arm. Up to 30 participants will be treated in Phase 2. Participants may receive treatment for 1 year (~17 cycles).
Group II: Phase 1Experimental Treatment2 Interventions
This "Run In" phase is aimed to determine if poly-ICLC can be safely combined with standard dosages of pembrolizumab: i. Pembrolizumab will be administered 200 mg intravenously (IV) every 3 weeks (q3w) ii. Poly-ICLC will be administered intramuscularly (IM) twice weekly at one of two dose levels: 1 mg or 2 mg Each dose level will enroll 3-6 participants, up to 12 participants total, depending on the occurrence of dose limiting toxicities (DLT) at each dosing level. Participants may receive treatment for 1 year (~17 cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Poly-ICLC
2016
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Asha NayakLead Sponsor
1 Previous Clinical Trials
4 Total Patients Enrolled
Oncovir, Inc.Industry Sponsor
23 Previous Clinical Trials
617 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,516 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab + Poly-ICLC in MRP Colon Cancer
Asha Nayak 2018. "Pembrolizumab + Poly-ICLC in MRP Colon Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02834052.
~4 spots leftby Apr 2025
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