RecruitingPhase 2NCT05538091

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

Phase II Clinical Trial Combining the Hedgehog Inhibitor Vismodegib With the PD-L1 Inhibitor Atezolizumab in Patients With Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer


Sponsor

Ronald Buckanovich

Enrollment

48 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of vismodegib (a targeted drug that blocks a cell growth pathway called Hedgehog) plus atezolizumab (an immunotherapy drug) for women with platinum-resistant ovarian, fallopian tube, or peritoneal cancer. Platinum resistance means the cancer stopped responding to standard platinum-based chemotherapy within 6 months, making it very hard to treat. **You may be eligible if:** - You have confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer - Your cancer progressed during or within 6 months of completing platinum-based chemotherapy - You have measurable or evaluable disease on scans - Your general health is adequate (ECOG score 0–2) **You may NOT be eligible if:** - Your cancer has not been platinum-resistant - You have uncontrolled autoimmune disease - You have had severe allergic reactions to similar immunotherapy drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVismodegib

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.

DRUGAtezolizumab

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.


Locations(1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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NCT05538091


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