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Antimetabolites
Pembrolizumab for Rectal Cancer
Phase 2
Waitlist Available
Led By Thomas J George
Research Sponsored by National Cancer Institute (NCI)
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 up to 3 years
Awards & highlights
Study Summary
This trial is testing two different drugs to see if they can help treat rectal cancer when used with combination chemotherapy and radiation therapy.
Eligible Conditions
- Rectal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neoadjuvant Rectal Cancer (NAR) Score
Secondary outcome measures
Disease Free Survival
Overall Survival
Rate of Pathologic Complete Response (Nodes and Tumor) ypT0 and ypN0
+1 moreOther outcome measures
Correlative Molecular Predictors of Response and Distant Failure
Incidence of Toxicity Including Patient-reported Toxicities
Proportion of Patients Who Have a Tumor Resection Overall (and Conditional on Beginning Induction Chemotherapy, and Conditional on Beginning Chemoradiotherapy)
+7 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
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (mFOLFOX6, RT, capecitabine, pembrolizumab)Experimental Treatment6 Interventions
ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (mFOLFOX6, RT, capecitabine, veliparib)Experimental Treatment6 Interventions
Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity.
Group III: Arm I (mFOLFOX6, RT, capecitabine)Active Control5 Interventions
Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Participants assigned to Arm I concurrently with Arm II or with Arm III.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Pembrolizumab
2017
Completed Phase 2
~2010
Veliparib
2012
Completed Phase 3
~4820
Capecitabine
2013
Completed Phase 3
~3420
Fluorouracil
2014
Completed Phase 3
~11540
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,278 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,489 Total Patients Enrolled
Thomas J GeorgePrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have signed a form that says you agree to participate in the study and that meets the rules set by the government and the institution.A tumor measuring at least 4 cm on MRI or CT scan, or any tumor that is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan is considered bulky.You are pregnant or breastfeeding.You have other illnesses or medical conditions that could make it difficult to safely understand the effects of the study drug or make it hard for you to attend follow-up appointments.You have had a previous invasive cancer in your rectum.You have an ongoing autoimmune disease that requires medication to control it, and you've needed this medication for the past two years.You have received a live vaccine within the past 28 days before the trial.You can swallow pills and keep them down.You have an unstable heart condition.You have a condition that weakens your immune system or have been taking medications that lower your immune system within a week before starting the study treatment.You cannot have a specific type of surgical procedure before receiving treatment.You have seizures that are not controlled by medication.You have previously taken the experimental drug being tested in this study.You have received radiation treatment to your pelvic area as part of previous therapy.You are able to perform daily activities without assistance, or with some assistance due to your medical condition.The surgeon plans to either preserve or remove the sphincter muscle during surgery.Your surgeon has determined that it is not possible to remove the cancer without removing the sphincter muscle.OS
The distal location is anything that is five centimeters or less from the anal verge according to a magnetic resonance imaging (MRI), transrectal ultrasound (ERUS)/pelvic computed tomography (CT) [with IV contrast] scan, or palpable on digital rectal examination (DRE).)
A computed tomography scan with intravenous contrast may be used to determine the clinical stage of the cancer, if it is known that the cancer has spread to the lymph nodes.The tumor is located a certain distance away from the anus.You have 4 or more lymph nodes that are at high risk for spreading cancer to other parts of your body. These nodes are located near your rectum and have a size of at least 1.0 centimeter as determined by imaging tests.The tumor needs to be located within 12 centimeters from the anal verge or below the peritoneal reflection, as determined by the surgeon.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (mFOLFOX6, RT, capecitabine, pembrolizumab)
- Group 2: Arm I (mFOLFOX6, RT, capecitabine)
- Group 3: Arm II (mFOLFOX6, RT, capecitabine, veliparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please summarize the findings of the Pembrolizumab clinical trials in terms of patient safety?
"Pembrolizumab has received a safety score of 2. This is due to the fact that, while there have been Phase 2 trials-- meaning some data supporting safety exists-- there is no evidence currently suggesting efficacy."
Answered by AI
Pembrolizumab is typically given to patients with what condition?
"Pembrolizumab is an immunotherapy agent used to treat aggressive cancers such as malignant neoplasms and unresectable melanoma. It can also be effective for patients with microsatellite instability high."
Answered by AI
What are some other ways Pembrolizumab has been studied in the past?
"Presently, there are a total of 1736 clinical trials researching pembrolizumab. Out of these active studies, 368 are in phase 3. The majority of research locations for pembrolizumab are situated in Guangzhou, Guangdong; however, there are 65868 medical centres running trials for this treatment worldwide."
Answered by AI
In how many places is this experiment being conducted?
"Currently, this study is taking place in 100 different medical centres. If you are considering participating in the trial, know that Two Rivers, Kearney and Baltimore are some of the locations where it is running--amongst 100 other places. By selecting the site closest to you, you can reduce travel time and effort."
Answered by AI
How many individuals are taking part in this clinical trial?
"Unfortunately, this particular clinical trial is no longer recruiting patients. It was initially posted on October 12th, 2016 and last edited on October 18th, 2022. However, there are currently 325 trials actively searching for patients with cancer of the rectum and 1736 trials for Pembrolizumab looking for participants."
Answered by AI
Are participants still being accepted for this experiment?
"This study is no longer recruiting patients. The clinical trial was initially posted on 10/12/2016 and last updated on 10/18/2022. If you are searching for other studies, there are presently 325 trials actively enrolling patients with cancer of the rectum and 1736 studies for Pembrolizumab actively searching for participants."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
How old are they?
65+
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria
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