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

 Renal Cell Carcinoma / Posted 5 months 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.
  • 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 start date : May 22, 2019
  • Study end date : April 29, 2025
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Novartis Pharmaceuticals
Contact details

Novartis Investigative Site The Royal Marsden Hospital Fulham RoadLondon,England,SW3 6JJ  Show Phone Number novartis.email@novartis.com www.royalmarsden.nhs.uk

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