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New combo therapy shows promise in advanced cancer trial

NCT ID NCT03798626

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new drug called gevokizumab alongside standard cancer treatments in 167 adults with advanced colorectal, stomach, or kidney cancer that had spread. The goal was to find a safe and active dose and see if the combination could help control the disease. While not a cure, the study aimed to improve treatment options for people with these hard-to-treat cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

167 people

The number who actually took part.

Started

May 2019

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: For All Cohorts: * Adult ≥ 18 years old. * Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy. * Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. * Adequate bone marrow and organ function per defined criteria in the protocol. * Recovered from acute laboratory and clinical toxicities of prior anti cancer treatment to NCI CTCAE v5.0 grade ≤1 at time of screening, except alopecia and amenorrhea. For Cohort A: • First line metastatic colorectal adenocarcinoma. For Cohort B: • Second line metastatic colorectal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin. For Cohort C: • Second line metastatic gastroesophageal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet. For Cohort D: • Second or third line metastatic renal cell carcinoma with a clear cell component and has received one or two lines of treatment for metastatic disease that included an anti angiogenic agent for at least 4 weeks with radiologic progression on that treatment. For subjects starting from Part 1a in Cohorts A and B: * Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment). * Not requiring immediate initiation of anti cancer therapy per investigator's best judgement. For subjects starting from Part 2 in Cohort C: • Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment). Key Exclusion Criteria: For All Cohorts: * Currently receiving any of the prohibited medications or has contraindications as outlined in the 'Contraindications' to SOC regimen components. * Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery). * Suspected or proven immunocompromised state, or infections (as defined in the protocol). * Conditions that have a high risk of clinically significant bleeding after administration of anti VEGF agents. * Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease. For Cohort D: * Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. * Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib. Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma colorectal adenocarcinoma colorectal cancer colorectal neoplasm gastroesophageal adenocarcinoma gastroesophageal cancer renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Gastroesophageal cancer Renal cell carcinoma

Contacts and locations

Locations

  • Novartis Investigative Site

    Melbourne, Victoria, 3000, Australia

  • Novartis Investigative Site

    Brussels, 1000, Belgium

  • Novartis Investigative Site

    Edegem, 2650, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Calgary, Alberta, T2N4N2, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8330074, Chile

  • Novartis Investigative Site

    Brno, 656 53, Czechia

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60488, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464 8681, Japan

  • Novartis Investigative Site

    Kashiwa, Chiba, 2778577, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5418567, Japan

  • Novartis Investigative Site

    Sunto Gun, Shizuoka, 411 8777, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28050, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    London, SW3 6JJ, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • University of California LA

    Los Angeles, California, 90095, United States

  • WA Uni School Of Med

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.