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Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers

Trial Status: Active

This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary efficacy of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.

Inclusion Criteria

  • Inclusion Criteria: - Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy. - Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1. For Cohort A: - First line metastatic colorectal cancer. For Cohort B: - Second line metastatic colorectal cancer that has progressed on prior chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin. For Cohort C: - Second line metastatic gastroesophageal cancer that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet. For Cohort D: - Second or third line metastatic renal cell carcinoma with a clear-cell component and has received one or two lines of treatment for metastatic disease that included an anti-angiogenic agent for at least 4 weeks with radiologic progression on that treatment. For subjects starting from Part 1a in Cohorts A and B: - Serum hs-CRP at screening ≥ 10 mg/L. - Not requiring immediate initiation of anti-cancer therapy per investigator's best judgement. For subjects starting from Part 2 in Cohorts C and D: - Serum hs-CRP at screening ≥ 10 mg/L. Exclusion Criteria: For All Cohorts: - Currently receiving any of the prohibited medications or has contraindications as outlined in the protocol. - Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery). - Suspected or proven immunocompromised state, or infections (as defined in the protocol). - Conditions that have a high risk of clinically significant bleeding after administration of anti-VEGF agents. - Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease. For Cohort D: - Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. - Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib. Other protocol-defined inclusion/exclusion criteria may apply

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Scottsdale
Mayo Clinic in Arizona
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Ruth Gonzalez
Phone: 310-794-4376
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: APPROVED

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Novartis Pharmaceuticals Corporation

  • Primary ID CVPM087A2101
  • Secondary IDs NCI-2019-04426, 2018-003952-19
  • Clinicaltrials.gov ID NCT03798626