167 Participants Needed

Gevokizumab + Standard Cancer Therapy for Colorectal and Gastroesophageal Cancers

Recruiting at 44 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
Must be taking: Anti-cancer therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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.

Inclusion 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 clear-cell renal cancer, treated with an anti-angiogenic agent but it progressed.
See 6 more

Exclusion Criteria

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.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gevokizumab in combination with standard of care anti-cancer therapies

6 weeks
Multiple visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Gevokizumab
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Cohort D: 2nd or 3rd line renal cell carcinomaExperimental Treatment2 Interventions
Group II: Cohort C: 2nd line gastroesophageal cancerExperimental Treatment3 Interventions
Group III: Cohort B: 2nd line colorectal cancerExperimental Treatment3 Interventions
Group IV: Cohort A: 1st line colorectal cancerExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

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