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

Phase Ib Study of Gevokizumab in Combination With Standard of Care Anti-cancer Therapies in Patients With Metastatic Colorectal Cancer, Gastroesophageal Cancer and Renal Cell Carcinoma

ClinicalTrials.gov Identifier: NCT03798626

Novartis Reference Number: CVPM087A2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary efficacy 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.

Condition 
Colorectal Cancer
Gastroesophageal Cancer
Renal Cell Carcinoma
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
172 participants
Start date 
May 22, 2019
Completion date 
Jul 23, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Gevokizumab
60 mg/mL concentration; administered intravenously (IV)
Drug
Bevacizumab
25 mg/mL concentration; administered IV
Drug
Modified FOLFOX6
Oxaliplatin [5 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV]
Drug
FOLFIRI
Irinotecan [20 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV]
Drug
Ramucirumab
10 mg/mL concentration; administered IV
Drug
Paclitaxel
6 mg/mL concentration; administered IV
Drug
Cabozantinib
60 mg tablet; administered orally

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 Cohorts C and D:

- 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 Locations

United States
Mayo Clinic Arizona Reg-2
Recruiting
Phoenix, 85054
Arizona
United States
Honor Health Research Institute
Recruiting
Scottsdale, 85258
Arizona
United States
University of California at Los Angeles UCLA Oncology Clinic
Recruiting
Los Angeles, 90095
California
United States
Sarah Cannon Research Institute Drug Ship - 4
Recruiting
Nashville, 37203
Tennessee
United States
Australia
Novartis Investigative Site
Recruiting
Woodville, 5011
South Austrailia
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Austria
Novartis Investigative Site
Recruiting
Salzburg, 5020
-
Austria
Novartis Investigative Site
Recruiting
Wien, A-1090
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1000
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1Z6
Ontario
Canada
Chile
Novartis Investigative Site
Active, not recruiting
Santiago, 8330074
-
Chile
Czechia
Novartis Investigative Site
Recruiting
Brno, 656 53
Czech Republic
Czechia
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60488
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89081
-
Germany
Hong Kong
Novartis Investigative Site
Withdrawn
Pokfulam,
-
Hong Kong
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 52621
-
Israel
Novartis Investigative Site
Recruiting
Tel Aviv, 6423906
-
Israel
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Japan
Novartis Investigative Site
Recruiting
Nagoya, 464 8681
Aichi
Japan
Novartis Investigative Site
Recruiting
Kashiwa, 277 8577
Chiba
Japan
Novartis Investigative Site
Recruiting
Osaka-city, 541-8567
Osaka
Japan
Novartis Investigative Site
Recruiting
Sunto Gun, 411 8777
Shizuoka
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119074
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
Recruiting
Valencia, 46010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08907
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28034
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28050
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Tainan, 70403
-
Taiwan
United Kingdom
Novartis Investigative Site
Recruiting
London, SW3 6JJ
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111

Have a question?

Call 1-999-669-6682 or email [email protected]