Kidney Cancer Clinical Trial

Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

For Cohort A:

- First line metastatic colorectal cancer.

For Cohort B:

- Second line metastatic colorectal cancer that has progressed on prior chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin.

For Cohort C:

- Second line metastatic gastroesophageal cancer 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.
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.

Exclusion Criteria:

For All Cohorts:

Currently receiving any of the prohibited medications or has contraindications as outlined in the protocol.
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

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

167

Study ID:

NCT03798626

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 33 Locations for this study

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University Of California LA UCLA Oncology Clinic
Los Angeles California, 90095, United States
WA Uni School Of Med Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Sarah Cannon Research Institute Drug Ship - 4
Nashville Tennessee, 37203, United States
Novartis Investigative Site
Melbourne Victoria, 3000, Australia
Novartis Investigative Site
Edegem Antwerpen, 2650, Belgium
Novartis Investigative Site
Bruxelles , 1000, Belgium
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Calgary Alberta, T2N 4, Canada
Novartis Investigative Site
Toronto Ontario, M5G 1, Canada
Novartis Investigative Site
Santiago , 83300, Chile
Novartis Investigative Site
Brno Czech Republic, 656 5, Czechia
Novartis Investigative Site
Dresden , 01307, Germany
Novartis Investigative Site
Frankfurt , 60488, Germany
Novartis Investigative Site
Ulm , 89081, Germany
Novartis Investigative Site
Ramat Gan , 52621, Israel
Novartis Investigative Site
Tel Aviv , 64239, Israel
Novartis Investigative Site
Milano MI, 20162, Italy
Novartis Investigative Site
Rozzano MI, 20089, Italy
Novartis Investigative Site
Nagoya Aichi, 464 8, Japan
Novartis Investigative Site
Kashiwa Chiba, 277 8, Japan
Novartis Investigative Site
Osaka-city Osaka, 541-8, Japan
Novartis Investigative Site
Sunto Gun Shizuoka, 411 8, Japan
Novartis Investigative Site
Bunkyo-ku Tokyo, 113-8, Japan
Novartis Investigative Site
Seoul , 05505, Korea, Republic of
Novartis Investigative Site
Singapore , 11907, Singapore
Novartis Investigative Site
Sevilla Andalucia, 41013, Spain
Novartis Investigative Site
Hospitalet de LLobregat Catalunya, 08907, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
Madrid , 28009, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Madrid , 28050, Spain
Novartis Investigative Site
Tainan , 70403, Taiwan
Novartis Investigative Site
London , SW3 6, United Kingdom
Novartis Investigative Site
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

167

Study ID:

NCT03798626

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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