Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
Colon/Rectal Cancer
Esophogeal Cancer
Stomach/ Gastric Cancer
18 Years and older, Male and Female
CVPM087A2101 (primary)
NCI-2019-04426
2018-003952-19
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.
Eligibility
- 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
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