A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04704154|
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : June 7, 2021
Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.
In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts.
The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion).
The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years.
During the trial, the doctors will take pictures of the participants' tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Regorafenib, (Stivarga, BAY73-4506) Drug: Nivolumab (Opdivo)||Phase 2|
|Study Type :||Interventional|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-indication, Single-treatment Arm, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients With Recurrent or Metastatic Solid Tumors|
|Actual Study Start Date :||February 3, 2021|
|Estimated Primary Completion Date :||July 13, 2023|
|Estimated Study Completion Date :||December 21, 2024|
Parallel-cohort in adult participants with selected recurrent or metastatic tumors (HNSCC, ESCC, PDAC, BTC, and GBM/AA) who have been previously treated with one or more systemic therapy for the selected tumor indication.
Drug: Regorafenib, (Stivarga, BAY73-4506)
Intake orally, starting with 3x 30 mg tablets every day (once daily.) for 21 days of every 28-day cycle (21 days on, 7 days off).
If the starting dose is well tolerated dose can be escalated to 120 mg (4x30 mg tablets).
Drug: Nivolumab (Opdivo)
480 mg administered on Day 1 of each treatment cycle.
- Overall response rate (ORR) [ Time Frame: Up to the last participant having been followed for approximately 10 months, summing up to approximately 2.5 years ]
- Per Response evaluation criteria in solid tumors 1.1 (RECIST 1.1) by local assessment for all solid tumors except GBM/AA (Glioblastoma multiforme/Anaplastic astrocytoma)
- Per Response assessment in neuro-oncology (RANO) by local assessment for GBM/AA
- Duration of response (DOR) [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]
- Disease control rate (DCR) [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]
- Progression free survival (PFS) [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]
- 6 months PFS [ Time Frame: 6 months ]
- Overall survival (OS) [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]
- 1 year OS [ Time Frame: 1 year ]
- Severity of AEs (adverse events) per CTCAE v 5.0 [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]CTCAE: Common terminology criteria for adverse events
- Number of participants with adverse events [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704154
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