Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Colorectal Cancer Metastatic

In brief

This phase I/II studies the side effects and best dose of regorafenib when given together with pembrolizumab in treating participants with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as regorafenib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and pembrolizumab may work better at treating colorectal cancer.

Key facts

Study ID: NCT03657641
Run by: University of Southern California
People needed: 73
Starts: 2019-06-21
Expected to finish: 2027-12-31
Last updated by the study team: 2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients who provided written informed consent to be subjects in this trial
Patients with histologically or cytologically confirmed advanced or metastatic colorectal cancer who had failed or are intolerant of oxaliplatin, irinotecan, and fluorouracil (5-FU)
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Patients capable of taking oral medication
Patients with evaluable or measurable lesions as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Neutrophil count >= 200/mm\^3
Platelet count >= 7.5 x 10\^4/mm\^3 (transfusion > 2 weeks before testing permitted)
Aspartate transaminase (AST), alanine transaminase (ALT) =< 2.5-times the upper limit of normal (=< 5-times in patients with liver metastasis)
Total bilirubin =< 1.5-times the upper limit of normal
Creatinine =< 1.5-times the upper limit of normal
Lipase =< 1.5 x the upper limit of normal (ULN)
International normalized ratio (INR) =< 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g. heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care
In women with the potential for pregnancy (including patients with amenorrhea due to medical reasons, such as chemical menopause), after consenting to the study, the patient must agree to take contraception for at least 23 weeks after taking the final dose of the investigational drug (a period of 30 days [ovulation cycle] is added to five times the elimination half-time of I/O agent). Women with the potential for pregnancy include those who have begun menstruation, who have not undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, and who have not gone through menopause. Menopause is defined as the consecutive absence of menstrual periods for >= 12 months
In the case of men, the patient must agree after consenting to the study to take contraception for at least 31 weeks after taking the final dose of the investigational drug (a period of 90 days [the spermatogenesis cycle] is added to five times the elimination half-time of immuno-oncology (I/O) agent

You may not qualify if…

Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy < 2 weeks before enrollment. Immune checkpoint blockade as pretreatment is permitted
Patients with a history of taking regorafenib
Patients with hypertension that is difficult to control (systolic blood pressure >= 150 mmHg and diastolic blood pressure >= 90 mmHg) despite treatment with several hypotensive agents
Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment
Patients with a large amount of pleural effusion or ascites requiring more than weekly drainage
Patients with a >= grade 3 active infection according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Patients with symptomatic brain metastasis
Patients with partial or complete gastrointestinal obstruction
Patients with interstitial lung disease with symptoms or signs of activity
Patients who test positive for either anti-human immunodeficiency virus (HIV)-1 antibodies, anti-HIV-2 antibodies, anti-human T-lymphotropic virus (HTLV)-1 antibodies, hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibodies*
Patients who test positive for either anti-hepatitis B surface antigen (HBs) or anti-hepatitis B core antigen (HBc) antibodies, and those who have hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) measurements greater than the detection sensitivity will also be excluded
Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease
Patients who require systemic corticosteroids (excluding temporary usage for tests, prophylactic administration for allergic reactions, or to alleviate swelling associated with radiotherapy) or immunosuppressants, or who have received such a therapy < 14 days before enrollment in the present study
Patients with a history or findings of >= grade III congestive heart failure according to the New York Heart Association functional classification
Patients with a seizure disorder who require pharmacotherapy
Persistent proteinuria > 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (>= grade 3, NCI-CTCAE version [v] 4.0)
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
Major surgical procedure or significant traumatic injury within 28 days before start of study medication
Non-healing wound, non-healing ulcer, or non-healing bone fracture
Patients with evidence or history of any bleeding diathesis, irrespective of severity
Any hemorrhage or bleeding event >= CTCAE grade 3 within 4 weeks prior to the start of study medication
Women who are pregnant or breastfeeding, or with the potential for pregnancy
EXCLUDED THERAPIES AND MEDICATIONS, PREVIOUS AND CONCOMITANT
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib and pembrolizumab)
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 2 weeks of trial entry (signing of the informed consent form is OK in the washout period)

Where it is running

City of Hope — Duarte, California, United States
USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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