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Antimetabolite

Pembrolizumab + Standard Care for Rectal Cancer

Phase 1
Recruiting
Led By David Liska, MD
Research Sponsored by Case Comprehensive Cancer Center
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 4-6 weeks before intervention
Awards & highlights

Study Summary

This trial is testing an investigational drug called Pembrolizumab in combination with the standard of care (SOC) for locally advanced rectal cancer, which includes neoadjuvant chemotherapy and radiation followed by surgery. Mismatch repair deficient locally advanced rectal cancer is a type of cancer that is difficult to treat because patients often do not respond well to the SOC. The purpose of this study is to see if Pembrolizumab can improve treatment outcomes for these patients.

Who is the study for?
This trial is for adults with a specific type of rectal cancer that's mismatch repair deficient (dMMR) or has high microsatellite instability (MSI-H). They should be fit enough for chemotherapy and surgery, have not had prior treatment for rectal cancer, and must not have severe heart conditions, active infections like HIV or hepatitis, ongoing pregnancy, certain autoimmune diseases, or any psychiatric conditions that could affect participation.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Pembrolizumab (an immune therapy drug), along with standard radiation therapy and Capecitabine (a chemotherapy drug), in treating locally advanced rectal cancer. The goal is to see if this combination can improve patient responses compared to the current treatments.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver issues, skin reactions, hormone gland problems like thyroid disorders. Radiation might lead to fatigue and skin irritation at the site of treatment. Capecitabine can cause hand-foot syndrome (redness/pain/swelling of hands/feet), diarrhea, nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks before intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks before intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility as defined by proportion of participants with any delay in planned surgery of more than 30 days
Proportion of participants able to complete planned neoadjuvant treatment protocol
Rate of adverse events (AEs) as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment3 Interventions
Experimental pembrolizumab and SOC external beam radiation and capecitabine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
External beam radiation
2005
Completed Phase 3
~600
Capecitabine
2013
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,900 Total Patients Enrolled
David Liska, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
2 Previous Clinical Trials
308 Total Patients Enrolled

Media Library

Capecitabine (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04357587 — Phase 1
Rectal Cancer Research Study Groups: Pembrolizumab
Rectal Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04357587 — Phase 1
Capecitabine (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04357587 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts for this experiment ongoing at this time?

"Yes, as indicated on clinicaltrials.gov, this trial is currently recruiting patients. The trial was originally posted on 8/6/2020 and was most recently updated on 9/7/2022."

Answered by AI

What other scientific papers exist that feature Pembrolizumab?

"Pembrolizumab is being trialed in 1327 clinical studies, with 246 of those in Phase 3. The global study is based in Houston, Texas, but has 46880 locations running trials."

Answered by AI

What are some of the cancers that Pembrolizumab is used against?

"Pembrolizumab is commonly used to fight cancerous neoplasms. In addition, it can be used to treat conditions such as unresectable melanoma, microsatellite instability high, and high risk of recurrence."

Answered by AI

At present, how many people are enrolled in this experiment?

"According to the information available on clinicaltrials.gov, this trial is still actively looking for participants. The listing was first posted on August 6th, 2020 and was updated September 7th, 2020. They are specifically recruiting for 10 people to participate at 1 location."

Answered by AI

Does Pembrolizumab present any life-threatening risks?

"Pembrolizumab falls into the Phase 1 category, which means that there is only minimal data supporting its safety and efficacy. Power gave it a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer
2020. "Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04357587.
~2 spots leftby Apr 2025
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