Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
Renal Cell Carcinoma / Posted 1 year ago
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.
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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.
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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 start date : May 22, 2019
- Study end date : April 29, 2025
- Wales-Based Study Contact : Please speak to your clinician
- Principal Investigator : Novartis Pharmaceuticals