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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03798626
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Gevokizumab — DRUG
    60 mg/mL concentration; administered intravenously (IV)
  • Bevacizumab — DRUG
    25 mg/mL concentration; administered IV
  • Modified FOLFOX6 — DRUG
    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 \[50 mg/mL concentration; administered IV\]
  • FOLFIRI — DRUG
    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 \[50 mg/mL concentration; administered IV\]
  • Ramucirumab — DRUG
    10 mg/mL concentration; administered IV
  • Paclitaxel — DRUG
    6 mg/mL concentration; administered IV
  • Cabozantinib — DRUG
    60 mg tablet; administered orally

Study Details

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.

Key Dates

Start date
May 22, 2019
Status verified
Mar 2026
Primary completion
Mar 1, 2023
Completion
Feb 5, 2025

Study Design

Enrollment
167 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: 1st line colorectal cancer
    Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab
  • Experimental: Cohort B: 2nd line colorectal cancer
    Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab
  • Experimental: Cohort C: 2nd line gastroesophageal cancer
    Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab
  • Experimental: Cohort D: 2nd or 3rd line renal cell carcinoma
    Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib

Primary Outcome Measure

Part 1a/b (Cohorts A and B): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy [ Time Frame: Baseline, Day 15 ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California LALos AngelesCalifornia90095-
WA Uni School Of MedSt LouisMissouri63110-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Los Angeles, CA

By condition
Colorectal cancerKidney cancer
By specialty
OncologyGI oncologyUrology
By research site
University of California LA· Los Angeles, CAWA Uni School Of Med· St Louis, MOSarah Cannon Research Institute· Nashville, TN

Related Studies