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Checkpoint Inhibitor

Vismodegib + Atezolizumab for Ovarian Cancer

Phase 2
Recruiting
Led By Ronald J Buckanovich, MD
Research Sponsored by Ronald Buckanovich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new combination of drugs to treat patients with ovarian cancer who have stopped responding to other treatments.

Who is the study for?
This trial is for adults with ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based chemotherapy. Participants need good organ function and blood work within normal ranges, no severe infections or heart issues recently, not on certain medications, and must agree to contraception if applicable. They should have a life expectancy of at least 3 months and an ECOG Performance Status of 0-1.
What is being tested?
The trial tests a combination treatment using Vismodegib and Atezolizumab in patients whose cancer hasn't responded well to platinum-based treatments. The goal is to see if this new approach can improve outcomes since current response rates are low with existing therapies.
What are the potential side effects?
Possible side effects include digestive issues like nausea, muscle cramps, hair loss from Vismodegib; fatigue, possible immune-related reactions such as inflammation in organs or skin rashes from Atezolizumab; increased risk of infection from both drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Safety Determined by Dose Limiting Toxicities (DLTs)
Secondary study objectives
Immune-modified Response Rate by imRECIST
Modified Response Rate by iRECIST
Overall Survival (OS)
+1 more

Side effects data

From 2020 Phase 4 trial • 35 Patients • NCT02436408
74%
Dysgeusia
66%
Myalgia
49%
Alopecia
34%
Fatigue
34%
Weight loss
34%
Anorexia
31%
Nausea
23%
Eye disorders - Other
20%
Spasticity
17%
Constipation
14%
Generalized muscle weakness
14%
Gastroesophageal reflux disease
11%
Back pain
11%
Vomiting
11%
Pain
11%
Nasal congestion
11%
Skin and subcutaneous tissue disorders - Other
9%
Arthralgia
9%
Dizziness
9%
Muscle weakness lower limb
9%
Eyelid function disorder
9%
Watering eyes
9%
Diarrhea
6%
Hyperglycemia
6%
Insomnia
6%
Arthritis
6%
Musculoskeletal and connective tissue disorder - Other
6%
Lung infection
6%
Anemia
6%
Cataract
6%
Abdominal pain
6%
Edema face
6%
Papulopustular rash
6%
Fall
6%
Skin ulceration
3%
Infections and infestations - Other
3%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
3%
Agitation
3%
Hyperkalemia
3%
Pain in extremity
3%
Erectile dysfunction
3%
Hallucinations
3%
Peripheral motor neuropathy
3%
Libido decreased
3%
Facial muscle weakness
3%
Epistaxis
3%
Dyspnea
3%
Pulmonary edema
3%
Hypoglycemia
3%
Sepsis
3%
Hypotension
3%
Heart failure
3%
Sinus bradycardia
3%
Acute coronary syndrome
3%
Acute kidney injury
3%
Aspiration
3%
Colitis
3%
Gastrointestinal disorders - Other
3%
Vascular disorders - Other
3%
Hearing impaired
3%
Tinnitus
3%
Blurred vision
3%
Dry eye
3%
Eye pain
3%
Chills
3%
Edema limbs
3%
General disorders and administration site conditions - Other
3%
Bruising
3%
Alanine aminotransferase increased
3%
Alkaline phosphatase increased
3%
Aspartate aminotransferase increased
3%
Creatinine increased
3%
Productive cough
3%
Sinus disorder
3%
Photosensitivity
3%
Pruritus
3%
Rash maculo-papular
3%
Urticaria
3%
Surgical and medical procedures - Other
3%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vismodegib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: vismodegib + atezolizumabExperimental Treatment2 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vismodegib
2015
Completed Phase 4
~1880
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Ronald BuckanovichLead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,386 Total Patients Enrolled
Ronald J Buckanovich, MDPrincipal InvestigatorUPMC Hillman Cancer Center

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05538091 — Phase 2
PARP Inhibitors Research Study Groups: vismodegib + atezolizumab
PARP Inhibitors Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05538091 — Phase 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538091 — Phase 2
~32 spots leftby Apr 2028
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