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PARP Inhibitor and PD-1 Inhibitor
Combination Drug Therapy for Cancer (DIDO Trial)
Phase 2
Recruiting
Led By Gregory Vidal, MD
Research Sponsored by West Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic, recurrent, or unresectable solid tumor with a pathogenic, or presumed pathogenic, somatic mutation of specific homologous recombination deficiency (HRD) gene mutations
Participant must have adequate organ function including specific criteria for absolute neutrophil count, platelets, hemoglobin, serum creatinine, total bilirubin, aspartate aminotransferase, alanine aminotransferase, INR or PT, and aPTT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
DIDO Trial Summary
This trial will look at the effects of a new combination drug treatment for people with certain types of cancer.
Who is the study for?
Adults with certain unresectable or metastatic solid tumors containing specific HRD gene mutations, who are in good physical condition (ECOG ≤ 1), and have proper organ function. Participants must agree to use effective contraception and not donate blood during the study. HIV-positive patients on successful treatment can join. Those with recent major surgery, other cancer treatments, or certain medical conditions are excluded.Check my eligibility
What is being tested?
The trial is testing a combination of niraparib and dostarlimab for effectiveness and safety in treating solid tumors with HRD gene mutations. It's an open-label, single-arm Phase 2 study where all participants receive the same drug combo without a comparison group.See study design
What are the potential side effects?
While not explicitly listed here, common side effects for drugs like niraparib may include nausea, fatigue, blood cell count changes leading to increased infection risk or bruising/bleeding tendencies; dostarlimab could cause immune-related reactions affecting various organs.
DIDO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread, can't be removed by surgery, and has specific genetic changes.
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My blood tests show my organs are working well.
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I can carry out all my usual activities without help.
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I am 18 years old or older.
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I agree to use effective birth control.
DIDO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR
Secondary outcome measures
Clinical benefit rate (CBR)
DIDO Trial Design
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
niraparib and dostarlimab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Combination drug
2019
Completed Phase 2
~1650
Find a Location
Who is running the clinical trial?
West Cancer CenterLead Sponsor
4 Previous Clinical Trials
565 Total Patients Enrolled
Gregory Vidal, MDPrincipal InvestigatorWest Cancer Center
Adam ElNaggar, MDPrincipal InvestigatorWest Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and agree to use effective birth control during the study.I have active hepatitis B or C.My cancer has spread, can't be removed by surgery, and has specific genetic changes.I haven't had a blood transfusion in the last 4 weeks.My blood tests show my organs are working well.I can carry out all my usual activities without help.I do not have brain metastases or any signs of bleeding in the brain.I do not have any serious, uncontrolled illnesses or infections.I have a BRCA1 or BRCA2 mutation and my cancer is one of the specified types.I haven't taken any colony stimulating factors in the last 4 weeks.I am willing to have a biopsy if my old cancer tissue samples are not usable.I haven't had significant radiation therapy affecting my bone marrow in the last 2 weeks.I have not received a live vaccine in the last 14 days.I have never had myelodysplastic syndrome or acute myeloid leukemia.I haven't been treated for any cancer other than my current one in the last 2 years.I am HIV-positive, on effective treatment, with undetectable viral load and CD4 count over 350.I am 18 years old or older.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I have never had interstitial lung disease.I understand the study and agree to participate by signing a consent form.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I had a severe reaction to previous immunotherapy, except for minor lab changes.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.I have an autoimmune disease treated with medication in the last 2 years.I agree to use effective birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
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.
Is the enrollment window for this research still open?
"According to the information shared on clinicaltrials.gov, this particular research initiative is no longer recruiting patients; although it was first posted August 1st 2021 and most recently updated three days later. However, there are presently one other trials enlisting volunteers."
Answered by AI
What have been the observed safety profiles of Combination drug?
"There is evidence of safety from clinical trials, but no data demonstrating its efficacy which resulted in a score of 2."
Answered by AI
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