Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies

Part of paid clinical trials in Westwood, Kansas.

Sponsor
Anwaar Saeed
Study ID
NCT03539822
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need. The investigators believe that modulating the tumor microenvironment with biologic agents like cabozantinib will have synergistic effect when combined with checkpoint-based immunotherapeutics like durvalumab in this patient population. This is a phase I/II, open label, multi-cohort trial looking at safety, tolerability and efficacy endpoints.

Key Dates

Start date
Oct 22, 2018
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
117 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib plus Durvalumab (Gastric & esophageal cancer cohort)
    Cabozantinib * By mouth (PO) once daily on days 1-28 of every 28 day cycle * Dose will be 40mg Durvalumab \*Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle
  • Experimental: Cabozantinib plus Durvalumab (Colorectal cancer cohort)
    Cabozantinib * By mouth (PO) once daily on days 1-28 of every 28 day cycle * Dose will be 40mg Durvalumab \*Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle
  • Experimental: Cabozantinib plus Durvalumab (Hepatocellular carcinoma cohort)
    Cabozantinib * By mouth (PO) once daily on days 1-28 of every 28 day cycle * Dose will be 40mg Durvalumab \*Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle
  • Experimental: Cabozantinib plus Durvalumab plus Tremelimumab (Hepatocellular carcinoma cohort)
    Cabozantinib * By mouth (PO) once daily on days 1-28 of every 28 day cycle * Dose will be 40mg Durvalumab \*Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle Tremelimumab \*Single dose of 300mg intavenous (IV) infusion on day 1 of cycle 1

Primary Outcome Measure

Phase I- Maximum Tolerated Dose (MTD) [ Time Frame: 9 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterWestwoodKansas66205-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Debra Diecks, RN
[email protected]
4126238364
Clare Grzejka, RN
[email protected]
412-623-4891

Find similar trials in Westwood, KS

By condition
Colorectal cancerGastric cancerLiver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Kansas Cancer Center· Westwood, KSUPMC Hillman Cancer Center· Pittsburgh, PA

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