Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer (NCT03712943) | Clinical Trial Compass
CompletedPhase 1
Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer
United States52 participantsStarted 2018-10-23
Plain-language summary
The main purpose of this study is to test the safety, tolerable side effects, and determine the highest tolerable dose of the combination of Regorafenib and Nivolumab. Researchers want to find out if this combination of Regorafenib and Nivolumab can help people with metastatic colorectal cancer with mismatch repair (MMR) proficiency.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed diagnosis of colorectal adenocarcinoma
* Proficient DNA mismatch repair (MMR) or stable microsatellite disease.
* Participants with the presence of at least one lesion with measurable disease as defined by 10mm in longest diameter for a soft tissue lesions or 15mm in short axis for a lymph node by RECIST 1.1 for response assessment.
* Participants must have received and progressed through or become intolerant to fluoropyrimidine, irinotecan, oxaliplatin, and bevacizumab, and if K-ras wild type, cetuximab or panitumumab containing therapies. Exceptions may apply.
* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1
* Estimated life expectancy over 3 months.
* Adequate bone marrow, liver and renal function.
* Participants must not have had chemotherapy, major surgery, monoclonal antibody therapy or experimental therapy within the 21 days prior to the start of regorafenib and nivolumab administration
* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 24 hours prior to the start of study drug and then every 4 weeks. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
* Participants (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the Informed Consent Form (ICF)…
What they're measuring
1
Maximum Tolerated Dose
Timeframe: Up to 12 months
Trial details
NCT IDNCT03712943
SponsorH. Lee Moffitt Cancer Center and Research Institute