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

  • STATUS
    Recruiting
  • End date
    Jan 28, 2025
  • participants needed
    172
  • sponsor
    Novartis Pharmaceuticals
Updated on 27 October 2022
paclitaxel
cancer
measurable disease
carcinoma
fluorouracil
metastasis
oxaliplatin
cabozantinib
fluoropyrimidine
metastatic colorectal cancer
bevacizumab
curative surgery
metastatic cancer
kidney cancer
folfiri regimen
metastatic renal cell carcinoma
modified folfox6 regimen

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.

Details
Condition Colorectal Cancer, Gastroesophageal Cancer, Renal Cell Carcinoma
Treatment Paclitaxel, bevacizumab, FOLFIRI, Cabozantinib, Ramucirumab, Gevokizumab, Modified FOLFOX6
Clinical Study IdentifierNCT03798626
SponsorNovartis Pharmaceuticals
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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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