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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
No Placebo-Only Group
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSecondary 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 moreSide effects data
From 2016 Phase 1 & 2 trial • 8 Patients • NCT0183513225%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~590
Cabozantinib
2020
Completed Phase 2
~2360
Bevacizumab
2013
Completed Phase 4
~5540
Paclitaxel
2011
Completed Phase 4
~5450
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
2,916 Previous Clinical Trials
4,253,718 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test shows high levels of a protein called hs-CRP.My colorectal cancer is in its first stage of spreading.I have a weakened immune system or an infection.I am not taking any medications that are not allowed in the study.I have brain metastases that cause symptoms or need specific treatment.I have clear-cell renal cancer, treated with an anti-angiogenic agent but it progressed.My cancer has spread, cannot be removed by surgery, and I have tissue samples available.Your blood test shows high levels of a protein called hs-CRP.I do not have conditions that increase my bleeding risk with anti-VEGF treatments.I am not taking any strong medication or supplements that affect liver enzymes.My stomach or esophagus cancer has worsened after first-line chemotherapy including platinum and fluoropyrimidine.I have a GI condition that could affect how my body absorbs medication.I have at least one tumor that can be measured on a scan.I haven't had serious heart problems in the last 6 months.My colorectal cancer has worsened after first-line treatment including a fluoropyrimidine and oxaliplatin.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: 1st line colorectal cancer
- Group 2: Cohort B: 2nd line colorectal cancer
- Group 3: Cohort C: 2nd line gastroesophageal cancer
- Group 4: Cohort D: 2nd or 3rd line renal cell carcinoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.