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

NCT03798626 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gevokizumab

60 mg/mL concentration; administered intravenously (IV)

DRUG

Bevacizumab

25 mg/mL concentration; administered IV

DRUG

Modified FOLFOX6

Oxaliplatin \[5 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\]

DRUG

FOLFIRI

Irinotecan \[20 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\]

DRUG

Ramucirumab

10 mg/mL concentration; administered IV

DRUG

Paclitaxel

6 mg/mL concentration; administered IV

DRUG

Cabozantinib

60 mg tablet; administered orally

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2023-03-01
Completion
2025-02-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Chile
  • Czechia
  • Germany
  • Israel
  • Italy
  • Japan
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03798626 on ClinicalTrials.gov