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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Safety Determined by Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Immune-modified Response Rate by imRECIST
Modified Response Rate by iRECIST
Overall Survival (OS)
+1 moreSide effects data
From 2020 Phase 4 trial • 35 Patients • NCT0243640874%
Dysgeusia
66%
Myalgia
49%
Alopecia
34%
Weight loss
34%
Anorexia
34%
Fatigue
31%
Nausea
23%
Eye disorders - Other
20%
Spasticity
17%
Constipation
14%
Generalized muscle weakness
14%
Gastroesophageal reflux disease
11%
Pain
11%
Nasal congestion
11%
Back pain
11%
Skin and subcutaneous tissue disorders - Other
11%
Vomiting
9%
Eyelid function disorder
9%
Watering eyes
9%
Muscle weakness lower limb
9%
Diarrhea
9%
Arthralgia
9%
Dizziness
6%
Lung infection
6%
Arthritis
6%
Papulopustular rash
6%
Fall
6%
Hyperglycemia
6%
Skin ulceration
6%
Abdominal pain
6%
Edema face
6%
Insomnia
6%
Anemia
6%
Cataract
6%
Musculoskeletal and connective tissue disorder - Other
3%
Libido decreased
3%
General disorders and administration site conditions - Other
3%
Acute coronary syndrome
3%
Tinnitus
3%
Productive cough
3%
Eye pain
3%
Acute kidney injury
3%
Aspiration
3%
Infections and infestations - Other
3%
Blurred vision
3%
Epistaxis
3%
Colitis
3%
Dyspnea
3%
Vascular disorders - Other
3%
Hearing impaired
3%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
3%
Pulmonary edema
3%
Sepsis
3%
Dry eye
3%
Bruising
3%
Alanine aminotransferase increased
3%
Alkaline phosphatase increased
3%
Aspartate aminotransferase increased
3%
Creatinine increased
3%
Pain in extremity
3%
Facial muscle weakness
3%
Peripheral motor neuropathy
3%
Erectile dysfunction
3%
Sinus disorder
3%
Photosensitivity
3%
Pruritus
3%
Rash maculo-papular
3%
Urticaria
3%
Surgical and medical procedures - Other
3%
Hypotension
3%
Gastrointestinal disorders - Other
3%
Hypoglycemia
3%
Chills
3%
Edema limbs
3%
Hyperkalemia
3%
Agitation
3%
Hallucinations
3%
Heart failure
3%
Sinus bradycardia
3%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vismodegib
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
2017
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
1,540 Previous Clinical Trials
567,881 Total Patients Enrolled
Ronald J Buckanovich, MDPrincipal InvestigatorUPMC Hillman Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for hepatitis B.I have not received a live vaccine in the last 4 weeks.My blood and organs are functioning well.My condition worsened within 6 months after finishing platinum-based chemotherapy.I have high calcium levels in my blood that are causing symptoms.I have had leptomeningeal disease.I have had cancer other than ovarian cancer in the last 5 years.I have active tuberculosis.I am fully active or can carry out light work.I have not had a severe infection in the last 4 weeks.I agree not to donate blood while on the study and for 2 years after stopping vismodegib.I am 18 years old or older.I haven't taken any immune-weakening drugs in the last 2 weeks.I have not had major surgery in the last 4 weeks.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.I frequently need procedures to remove excess fluid from my chest or abdomen.I have not taken any antibiotics by mouth or IV in the last 2 weeks.My cancer is confirmed in the ovary, fallopian tube, or peritoneum.I have a history of lung scarring or inflammation not caused by infections.I don't have any health issues that prevent me from taking new medications.I haven't had major heart problems in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: vismodegib + atezolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the key goals of this medical research?
"This clinical trial will evaluate the Objective Response Rate (ORR) for up to two weeks as its primary outcome. Secondary objectives encompass Overall Survival, Modified Response Rate by iRECIST, and Progression-free survival; all of which are quantified through RECIST v1.1 criteria or time from enrollment until death from any cause in case of OS."
Answered by AI
Is recruitment of participants still open for this trial?
"It appears that, according to clinicaltrials.gov, this particular medical trial is not currently enrolling applicants as the post was last updated on September 8th 2022. Nevertheless, a total of 2474 other trials are actively seeking out participants at present."
Answered by AI
Has the Food and Drug Administration given authorization for Vismodegib to be used?
"With some evidence of safety but no efficacy data, Vismodegib was given a score of 2 on our internal scale."
Answered by AI
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