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Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Phase Ib Study of Gevokizumab in Combination With Standard of Care Anti-cancer Therapies in Patients With Metastatic Colorectal Cancer, Gastroesophageal Cancer and Renal Cell Carcinoma

NCT03798626•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose 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, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For All Cohorts:
•Adult ≥ 18 years old.
•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.
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
•Adequate bone marrow and organ function per defined criteria in the protocol.
•Recovered from acute laboratory and clinical toxicities of prior anti cancer treatment to NCI CTCAE v5.0 grade ≤1 at time of screening, except alopecia and amenorrhea.
•For Cohort A:
•First line metastatic colorectal adenocarcinoma.
•For Cohort B:
+10 more criteria

Exclusion Criteria

•For All Cohorts:
•Currently receiving any of the prohibited medications or has contraindications as outlined in the 'Contraindications' to SOC regimen components.
•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.

Locations (34)

University of California LA

Los Angeles, California, United States

WA Uni School Of Med

St Louis, Missouri, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Edegem, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Santiago, Chile

Key Dates

Start Date

May 22, 2019

Primary Completion Date

March 1, 2023

Completion Date

February 5, 2025

Last Updated

January 27, 2026

Enrollment

167

ACTUAL participants

Conditions

Colorectal CancerGastroesophageal CancerRenal Cell Carcinoma

Interventions

Gevokizumab

DRUG

Bevacizumab

DRUG

Modified FOLFOX6

DRUG

FOLFIRI

DRUG

Ramucirumab

DRUG

Paclitaxel

DRUG

Cabozantinib

DRUG

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

View study

RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors