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Regorafenib + Nivolumab for Cancer
Study Summary
This trial is testing a combination of two drugs, regorafenib and nivolumab, to see if they are safe and effective in treating people with different types of solid tumors.
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.Trial Design
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Who is running the clinical trial?
Media Library
- I have head and neck cancer that got worse after treatment, including a PD-1/PD-L1 inhibitor.I have a history of heart problems.My pancreatic cancer worsened after treatment with gemcitabine or fluoropyrimidine.My cancer has spread to the lining of my brain or other parts of my body.I have head and neck cancer and haven't had PD-1/PD-L1 inhibitor therapy.I am 18 years old or older.I have biliary tract cancer and my condition worsened after treatment with specific chemotherapy drugs.I can sign the consent form and follow the study's rules.I need more than 4 mg of dexamethasone daily for my brain tumor symptoms.My throat cancer has been tested for HPV.I have had or currently have lung inflammation that needed steroids.I do not have uncontrolled heart rhythm problems.I have head and neck cancer and haven't had PD-1/PD-L1 inhibitor therapy.I agree to provide a recent biopsy of my tumor for the study.My recent blood and organ function tests are within normal ranges.I have a high-grade brain tumor and it has worsened after initial treatments.I have brain or spinal cancer symptoms but any previous treatments have been stable for 6 weeks.I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.I have had more than one treatment with specific immune therapies for my cancer.My primary cancer is in the brainstem or spinal cord.I do not have a severe infection.I have biliary tract cancer and my condition worsened after treatment with specific chemotherapy drugs.I am fully active or restricted in physically strenuous activity but can do light work.My liver enzymes are within the acceptable range for my condition.I have been diagnosed with a type of brain tumor.I have been treated with taxane for my recurring or spreading cancer.My blood pressure is often over 140/90 mmHg, even with treatment.My esophageal cancer has spread to nearby organs.I haven't had a heart attack or new/unstable chest pain in the last 6 months.I don't have any health issues that could affect the trial's results or my participation.I haven't had a stroke or blood clot in the last 6 months.My cancer is identified as dMMR/MSI-H or has NTRK fusions.I have hepatitis B or C, but it's under control or not active.I can swallow and absorb pills.I have been treated with regorafenib before.I haven't had cancer treatment in the last 14 days or within 5 half-lives of the medication.I have heart failure that affects my daily activities.I stopped PD-1/PD-L1 therapy because of side effects.I have head and neck cancer that got worse after treatment, including a PD-1/PD-L1 inhibitor.I am 18 years old or older.I agree to provide a recent biopsy of my tumor for the study.My cancer has returned or spread and doesn't respond to standard treatments anymore.I have a high-grade brain tumor and it has worsened after initial treatments.I have previously received immunotherapy for my cancer.My pancreatic cancer worsened after treatment with gemcitabine or fluoropyrimidine.My condition is esophageal squamous cell carcinoma (ESCC).I have or had lung scarring or interstitial lung disease.I can swallow and absorb pills.My esophageal cancer worsened after treatment with platinum or fluoropyrimidine.I can sign and follow the study's consent form and rules.My throat cancer has been tested for HPV.I am fully active or can carry out light work.My recent blood and organ function tests are within normal ranges.My cancer has returned or spread and doesn't respond to standard treatments anymore.My esophageal cancer worsened after treatment with platinum or fluoropyrimidine.
- Group 1: Regorafenib+Nivolumab
- 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
In how many different settings is this experiment being conducted?
"There are 11 total sites for this trial, including Henry Ford Health System in Detroit, Michigan, Rocky Mountain Cancer Centers in Aurora, Colorado, and H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida."
To your knowledge, does this research have any precedent?
"796 medical studies are currently underway to test the efficacy of nivolumab (Opdivo). Medarex first conducted a Phase 1 trial in 2010 with 127 patients. Since then, 327 similar trials have been completed across 2441 cities and 51 countries."
Has Nivolumab (Opdivo) been used in other research studies?
"Nivolumab (Opdivo), first studied in 2010, has had 327 completed clinical trials. As of now, there are 796 active studies being conducted with many taking place in Detroit, Michigan."
How many people suffering from this ailment can join this clinical trial?
"Recruitment for this trial has closed. The study was initially posted on February 3rd, 2021 and edited for the last time on October 20th, 2022. If you are looking for similar studies, 2678 trials involving tumors and 796 investigations using Nivolumab (Opdivo) are still recruiting patients."
Are there long-term risks associated with Nivolumab (Opdivo)?
"Nivolumab (Opdivo) is a phase 2 medication, meaning that while there is some evidence for its safety, none exists yet to support efficacy."
What are some off-label indications for Nivolumab?
"Nivolumab (Opdivo) is commonly used to treat malignant neoplasms, but it can also be effective in treating other conditions like unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Are people currently being signed up for this experiment?
"This clinical trial is not currently enrolling patients. This study was first posted on February 3rd, 2021 and was last updated on October 20th, 2022. However, there are 2678 other trials for patients with tumors recruiting and 796 studies involving Nivolumab that are still looking for participants."
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