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Gevokizumab + Standard Cancer Therapy for Colorectal and Gastroesophageal Cancers

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Cohort A: First line metastatic colorectal cancer
Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy
Must not have
For All Cohorts: Suspected or proven immunocompromised state, or infections (as defined in the protocol)
For All Cohorts: Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will study the best dose of gevokizumab to combine with standard cancer therapies for treating metastatic colorectal, gastroesophageal, and renal cell carcinomas.

Who is the study for?
This trial is for adults with metastatic colorectal, gastroesophageal, or renal cancers that can't be removed by surgery. Participants must have specific types of these cancers at certain stages and meet criteria like having a measurable lesion and not needing immediate cancer treatment. They cannot join if they've had recent significant cardiovascular issues, are on certain drugs, or have brain metastases.
What is being tested?
The study tests the drug gevokizumab combined with standard cancer treatments (like FOLFOX6 or FOLFIRI for colorectal cancer) to find the right dose and see how well it works. It's given to patients who've already tried some treatments without success.
What are the potential side effects?
Potential side effects include those common to anti-cancer therapies such as nausea, fatigue, increased risk of infection due to lowered immunity, bleeding complications related to anti-VEGF agents in the therapy mix, and possible adverse reactions specific to gevokizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My colorectal cancer is in its first stage of spreading.
Select...
My cancer has spread, cannot be removed by surgery, and I have tissue samples available.
Select...
I have at least one tumor that can be measured on a scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a weakened immune system or an infection.
Select...
I have brain metastases that cause symptoms or need specific treatment.
Select...
I do not have conditions that increase my bleeding risk with anti-VEGF treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1a (Dose finding): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy
Part 1b (Safety run-in): Number of DLTs [Cohort A and Cohort B]
Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs) [Cohort C and Cohort D]
+3 more
Secondary study objectives
Disease Control Rate (DCR) per investigator assessment using RECIST v1.1
Duration of response (DOR) per investigator assessment using RECIST v1.1
Number of patients with anti-drug antibodies for bevacizumab in the combination regimens
+12 more

Side effects data

From 2016 Phase 1 & 2 trial • 8 Patients • NCT01835132
25%
Upper respiratory tract infection
25%
Urinary tract infection
13%
Asthenia
13%
Bacterial test
13%
Biopsy skin
13%
Corneal thinning
13%
Decreased appetite
13%
Dizziness
13%
Dry skin
13%
Fatigue
13%
Foreign body in eye
13%
Haematuria
13%
Hemoglobin urine present
13%
Haemorrhoids
13%
Headache
13%
Hepatic enzyme increased
13%
Hordeolum
13%
Hyperlipidaemia
13%
Infection
13%
Influenza
13%
Influenza like illness
13%
Irritable bowel syndrome
13%
Joint injury
13%
Laceration
13%
Limb injury
13%
Lymph node pain
13%
Muscle strain
13%
Nasopharyngitis
13%
Nausea
13%
Ocular hyperaemia
13%
Oropharyngeal pain
13%
Pruritis generalized
13%
Rash
13%
Renal failure
13%
Rhinorrhoea
13%
Scleral thinning
13%
Sinusitis
13%
Tooth fracture
13%
Erythema
13%
Injection site discomfort
13%
Road traffic accident
13%
Abdominal pain
13%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gevokizumab

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort D: 2nd or 3rd line renal cell carcinomaExperimental Treatment2 Interventions
Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib
Group II: Cohort C: 2nd line gastroesophageal cancerExperimental Treatment3 Interventions
Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab
Group III: Cohort B: 2nd line colorectal cancerExperimental Treatment3 Interventions
Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab
Group IV: Cohort A: 1st line colorectal cancerExperimental Treatment3 Interventions
Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modified FOLFOX6
2018
Completed Phase 2
~390
Cabozantinib
2020
Completed Phase 2
~1760
Bevacizumab
2013
Completed Phase 4
~5540
Paclitaxel
2011
Completed Phase 4
~5810
Ramucirumab
2017
Completed Phase 3
~5050
Gevokizumab
2013
Completed Phase 2
~10
FOLFIRI
2005
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,837 Total Patients Enrolled

Media Library

Gevokizumab Clinical Trial Eligibility Overview. Trial Name: NCT03798626 — Phase 1
Kidney Cancer Research Study Groups: Cohort A: 1st line colorectal cancer, Cohort B: 2nd line colorectal cancer, Cohort C: 2nd line gastroesophageal cancer, Cohort D: 2nd or 3rd line renal cell carcinoma
Kidney Cancer Clinical Trial 2023: Gevokizumab Highlights & Side Effects. Trial Name: NCT03798626 — Phase 1
Gevokizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03798626 — Phase 1
~27 spots leftby Sep 2025
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