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Regorafenib + Pembrolizumab for Colorectal Cancer
Study Summary
This trial is testing regorafenib given with pembrolizumab to see if it is more effective than regorafenib given alone for patients with metastatic colorectal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607Trial Design
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Who is running the clinical trial?
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- I take medication to control my seizures.I haven't had severe bleeding in the last 4 weeks.I haven't received any live vaccines in the last 30 days and won't during the trial.I am taking steroids for reasons not related to immune system reactions.I am fully active or restricted in physically strenuous activity but can do light work.I have brain metastasis causing symptoms.I am not pregnant, breastfeeding, or planning to become pregnant.I am not receiving any cancer treatments other than regorafenib and pembrolizumab.I haven't had major surgery or a serious injury in the last 28 days.My colorectal cancer is advanced, and I can't tolerate standard treatments.I can take pills by mouth.My high blood pressure is hard to control even with multiple medications.I had a heart attack or unstable angina and received a stent or angioplasty within the last 6 months.I haven't had major surgery or a serious injury in the last 28 days.I have a history of bleeding disorders, regardless of severity.I agree to use contraception for 31 weeks after my last dose of the study drug.I do not have active hepatitis B.I am not on long-term steroids or immunosuppressants, nor have I taken them in the last 14 days.My blood clotting tests are within normal limits, or I am on stable blood thinners.I agree to use birth control for 23 weeks after my last dose if I can become pregnant.My urine test shows high protein levels.I am on blood thinners for treatment, not just for prevention.I have a wound, ulcer, or bone fracture that is not healing.I am not currently on, nor have I recently taken, any excluded medications.I have severe heart failure.I have taken regorafenib in the past.I need drainage for fluid in my chest or abdomen more than once a week.I have a blockage in my digestive tract.I haven't had cancer treatment except immune therapy in the last 2 weeks.I have active symptoms of interstitial lung disease.I have tested positive for HIV, HTLV-1, hepatitis B, or hepatitis C.I do not have a severe infection right now.
- Group 1: Treatment (pembrolizumab, regorafenib)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there still opportunities to join this experiment?
"Records provided by clinicaltrials.gov indicate that this specific medical trial is not presently enrolling participants, though it was initially posted on June 21st 2019 and last updated August 5th 2022. Fortunately, there are 2090 other active trials which may require patient participation."
To what medical maladies is Regorafenib commonly prescribed?
"Regorafenib can be employed to treat melanoma that is not possible to surgically remove, microsatellite instability high tumours, and those with a precarious tendency towards relapse."
What other investigations have been conducted pertaining to Regorafenib?
"Currently, there are 1,012 studies associated with Regorafenib; 127 of them have entered Phase 3. These trials primarily take place in Rochester, Minnesota although they can be found at 36453 sites around the world."
In what capacity is this clinical trial being implemented?
"Potential participants can join this medical trial at City of Hope in Duarte, Moffitt Cancer Center in Tampa, and Hoag Memorial Hospital in Newport Beach. Additionally, there are 4 other locations that are recruiting patients for the study."
How many individuals are enrolled in this trial?
"At the present time, this trial is no longer recruiting participants. As per records on clinicaltrials.gov, the project was first posted in June 21st 2019 and most recently updated on August 5th 2022. For those looking for alternative studies with metastatic colorectal cancer (crc), there are currently 1078 trials that need volunteers; 1012 Regorafenib related medical investigations are also actively seeking subjects as well."
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