Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT04126733
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological confirmed advanced, metastatic, or progressive pMMR/MSS adenocarcinoma of colon or rectum
* Participant must have progressed or be intolerant to prior systemic chemotherapy including fluoropyrimidines, irinotecan, oxaliplatin, anti-vascular endothelial growth factor (VEGF) therapy, and, if extended rat sarcoma viral oncogene homolog (RAS) wild type, an anti-epidermal growth factor receptor (EGFR) therapy. Exceptions may apply
* Participants must have adequate organ and marrow function defined by protocol-specified laboratory tests
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Measurable disease as determined by response evaluation criteria in solid tumors (RECIST) v1.1
* Provision of recently obtained tumor tissue as per protocol specified requirement
* Anticipated life expectancy greater than 3 months
* Be able to swallow and absorb oral tablets
Exclusion Criteria:
* Participants with Mismatch repair deficient (dMMR) / microsatellite instable-high (MSI-H) colorectal cancer
* Prior therapy with regorafenib, anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of immunotherapy to treat cancer
* Presence of active central nervous system (CNS) metastases; participants with stable CNS disease or previously treated lesions are eligible for study entry
* Poorly controlled hypertension, defined as a blood pressure consistently above 150/90 mmHg despite optimal medical management
* Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months before the start of study medication. Active pulmonary emboli or deep vein thrombosis that are significant or not adequately controlled on anticoagulation regimen
* Any hemorrhage or bleeding event ≥ National Cancer Institute - Common terminology criteria for adverse events (NCI-CTCAE) Grade 3 within 28 days prior to the start of study medication
* Participants with an active, known or suspected autoimmune disease
* History of interstitial lung disease or pneumonitis
* Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection
* Other protocol defined inclusion/exclusion criteria could apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04126733
Study Brief:
Protocol Section:
NCT04126733