Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Ronald Buckanovich
Study ID
NCT05538091
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hedgehog Inhibitor
  • PARP Inhibitor
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma

Eligibility Criteria

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

Interventions

  • Vismodegib — DRUG
    A small-molecule SMO inhibitor designed to specifically target the hedgehog pathway, a known driver of BCC. It systemically inhibits hedgehog pathway signaling. Following mutation, SMO is released from the inhibitory effect of PTCH and moves to the cell surface, activating GLI. GLI travels to the nucleus and initiates transcription of target genes that regulate basal cell growth and proliferation.
  • Atezolizumab — DRUG
    Atezolizumab is a humanized monoclonal antibody immune checkpoint inhibitor that selectively binds to PD-L1 to stop the interaction between PD-1 and B7.1 (CD80 receptors). The antibody still allows interaction between PD-L2 and PD-1.

Study Details

This trial will treat patients with platinum resistant ovarian, fallopian tube or primary peritoneal cancer as defined by a progression free interval within six months of completion of most recent platinum-based treatment with a combination of vismodegib and atezolizumab. Despite recent improvements in treatment of ovarian cancer with the introduction of PARP inhibitors, response rates to therapy in the platinum resistant setting remain dismal with response rates of only 10-20% reported for single agent cytotoxic therapies. Given the poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.

Key Dates

Start date
May 15, 2023
Status verified
Nov 2025
Primary completion
Mar 17, 2031
Completion
Mar 17, 2033

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: vismodegib + atezolizumab
    Vismodegib: fixed dose of 150 mg PO daily Atezolizumab: fixed dose of 1200 mg Q3W (1200 mg on Day 1 of each 21-day cycle)

Primary Outcome Measure

Safety Determined by Dose Limiting Toxicities (DLTs) [ Time Frame: Up to two weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Kelsey Mitch, BSN
[email protected]
412-641-2357
Lucia Borasso, BSN
[email protected]
4126413304
Ronald B Buckanovich, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

Related Studies