Gevokizumab + Standard Cancer Therapy for Colorectal and Gastroesophageal Cancers

No longer recruiting at 52 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must be taking: Anti-cancer therapy

Must not be taking: CYP3A4/5 inhibitors

Disqualifiers: Brain metastases, Immunocompromised, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of gevokizumab (an experimental treatment) when combined with standard cancer therapies for certain metastatic cancers, including colorectal, gastroesophageal, and renal cell carcinoma. The researchers seek to evaluate the effectiveness and tolerability of this combination. Suitable participants have metastatic cancer that has spread, is not treatable with surgery, and have already undergone other cancer treatments. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not clearly specify if you must stop taking your current medications, but it mentions that you cannot be on any prohibited medications or have contraindications with the standard cancer therapy. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that gevokizumab, when combined with other cancer treatments, is generally well-tolerated by patients. In one study, most participants did not experience severe side effects. However, two notable cases occurred: one patient experienced a significant drop in white blood cells, and another had low sodium levels. These side effects are serious enough to limit the safe dosage of the drug.

Overall, the safety of gevokizumab is considered acceptable, with most side effects being manageable. As gevokizumab continues to be studied, more information about its safety will become available. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Gevokizumab is unique because it targets the inflammatory pathways involved in cancer progression, setting it apart from standard treatments like chemotherapy and targeted therapies such as FOLFOX and FOLFIRI. Researchers are excited because Gevokizumab offers a new mechanism of action by blocking interleukin-1 beta (IL-1β), a key player in inflammation, which could potentially enhance the effectiveness of existing cancer therapies. This innovative approach might improve outcomes for patients with colorectal and gastroesophageal cancers, offering hope for better management of these challenging conditions.

What evidence suggests that this trial's treatments could be effective for metastatic colorectal and gastroesophageal cancers?

Research has shown that gevokizumab, when combined with standard cancer treatments, may aid in treating certain advanced cancers. In this trial, participants will be divided into cohorts based on their cancer type and treatment line. For colorectal cancer, previous studies reported progression-free survival (PFS) rates of 29% and 39.4%. For gastroesophageal cancer, the PFS rate was 20%, indicating some effectiveness. Gevokizumab targets inflammation, which can help slow cancer growth. Although these findings are preliminary, they offer hope that gevokizumab might help manage these cancers when combined with current treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: Cohort D: 2nd or 3rd line renal cell carcinoma Experimental Treatment 2 Interventions

Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib

Group II: Cohort C: 2nd line gastroesophageal cancer Experimental Treatment 3 Interventions

Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab

Group III: Cohort B: 2nd line colorectal cancer Experimental Treatment 3 Interventions

Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab

Group IV: Cohort A: 1st line colorectal cancer Experimental Treatment 3 Interventions

Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab

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

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.135

Phase Ib study of gevokizumab (GEVO) in combination ... The PFS rates were 29.0% (80% CI: 20.4, 38.2), 39.4% (80% CI: 29.8, 48.9), 20.0% (60% CI: 13.3, 27.6) in A/B/C, respectively.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03798626

Gevokizumab With Standard of Care Anti-cancer Therapies ... This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3780632/

Efficacy and Safety of Bevacizumab in Metastatic ... The use of bevacizumab with chemotherapy resulted in statistically significant increases in overall and progression-free survival for patients with mCRC.

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)30800-2/pdf

P 281 Introduction: Colorectal cancer (CRC) is one of the most frequent types of cancer in developed countries, which affects both genders, although its incidence ...

5. academic.oup.com academic.oup.com/annonc/article/30/Supplement_4/mdz155.283/5526501

P-284 Gevokizumab, an interleukin-1β (IL-1β) monoclonal ... Treatment with anti-IL-1β monoclonal antibody (mAb) canakinumab was associated with a dose-dependent reduction in lung cancer incidence and ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS3642

NSABP FC-12: A single-arm, phase II study to evaluate ... Gevokizumab has been validated in pre-clinical colon cancer ... colorectal cancer from an observational GALAXY study in CIRCULATE-Japan.

7. investors.xoma.com investors.xoma.com/news-events/press-releases/detail/355/first-patient-dosed-with-gevokizumab-in-collaborator

First Patient Dosed with Gevokizumab in Collaborator ... Gevokizumab is an investigational compound. Efficacy and safety have not been established. There is no guarantee that gevokizumab will become ...