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Alkylating agents
Pembrolizumab for Colorectal Cancer
Phase 1
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
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 initiation of study therapy until disease progression, approximately 2 years.
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat metastatic colorectal cancer that has resisted other treatments.
Eligible Conditions
- Colorectal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of study therapy until disease progression, approximately 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of study therapy until disease progression, approximately 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate to pembrolizumab and pemetrexed plus oxaliplatin
Objective Response Rate to pembrolizumab plus pemetrexed
Secondary outcome measures
Clinical Benefit Rate
Frequency of Adverse Events
Overall Survival
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment6 Interventions
Pembrolizumab + Pemetrexed + Oxaliplatin every 21 days. Folic Acid 5 days prior to first dose of pemetrexed and daily including 21 days after last dose of pemetrexed.
Dexamethasone twice daily on the day before, the day of, and the day after each dose of pemetrexed.
Vitamin B-12 7 days prior to first dose of pemetrexed, every 9 weeks, continue until 3 weeks after last dose of pemetrexed.
Group II: Cohort 1Experimental Treatment5 Interventions
Pembrolizumab + Pemetrexed every 21 days. Folic Acid 5 days prior to first dose of pemetrexed and daily including 21 days after last dose of pemetrexed.
Dexamethasone twice daily on the day before, the day of, and the day after each dose of pemetrexed.
Vitamin B-12 7 days prior to first dose of pemetrexed, every 9 weeks, continue until 3 weeks after last dose of pemetrexed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Dexamethasone
2007
Completed Phase 4
~2590
Pemetrexed
2014
Completed Phase 3
~5250
Oxaliplatin
2011
Completed Phase 4
~2560
Folic Acid
2008
Completed Phase 4
~7610
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,621 Previous Clinical Trials
3,216,589 Total Patients Enrolled
NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
136,955 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,109 Total Patients Enrolled
Frequently Asked Questions
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