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PD-1 Inhibitor
Dostarlimab + Niraparib for Penile Cancer
Phase 2
Recruiting
Led By Jad Chahoud, MD, MPH
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
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 24 months
Awards & highlights
Study Summary
This trial is testing a new combination treatment for advanced penile cancer that has stopped responding to other treatments.
Who is the study for?
This trial is for adults with advanced penile cancer that has returned or resisted treatment. They must have measurable disease, good organ function, and a life expectancy over 12 weeks. Only those who've had at most one prior therapy and no immune-oncology treatments can join. Participants need to agree to contraception use during the study.Check my eligibility
What is being tested?
The trial tests combining two drugs, Dostarlimab and Niraparib, on patients with relapsed/refractory penile cancer. It aims to assess how effective and safe this combination is when other treatments haven't worked.See study design
What are the potential side effects?
Potential side effects of Dostarlimab and Niraparib may include fatigue, nausea, skin reactions, blood cell count changes leading to increased infection risk or bleeding problems, liver enzyme alterations affecting liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Response Rate (ORR)
+2 moreSide effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Abdominal pain
22%
Dyspnea
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Flu like symptoms
4%
Leukocytosis
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Bruising
4%
Unknown infection
4%
Ascites
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Depression
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Head injury
4%
Hypokalemia
4%
Hyperkalemia
4%
Postnasal drip
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dostarlimab and Niraparib treatmentExperimental Treatment2 Interventions
Participants will be given 500 mg Dostarlimab IV every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks, along with 200 mg Niraparib by mouth once daily days 1-21 of all cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 2
~1000
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,457 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,791 Total Patients Enrolled
Jad Chahoud, MD, MPHPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung inflammation or a related condition that needed steroids.I have small, symptom-free brain metastases not needing steroids.I've had only one prior treatment for my cancer that either didn't work or caused side effects.I haven't taken more than 20 mg of steroids daily for the last 4 weeks.I do not have active cancer spread to my brain.I am fully active or have some restrictions but can still care for myself.I had a severe reaction to previous immunotherapy, except for minor lab changes.My organs are functioning well enough to start treatment.I have not had worsening heart problems in the last 6 months.I have not received a live vaccine recently before starting treatment.I have never been diagnosed with MDS or AML.I have had an organ transplant and take medication to suppress my immune system.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I've had surgery or radiation that affected more than 20% of my bone marrow.I have recovered from any major surgery or significant radiation therapy.I have an active hepatitis B or C infection.My penile cancer is at an advanced stage and cannot be surgically removed.I haven't had a blood transfusion in the last 4 weeks.My brain metastases have been treated and I've been stable for at least 4 weeks.I haven't had brain surgery or targeted brain radiation in the last 4 weeks.Side effects from my last chemotherapy are mild or gone, except for possible hair loss or numbness.I have an autoimmune disease that needed treatment recently or is severe.I haven't taken any colony stimulating factors recently.I do not have symptoms from brain metastases.I do not have an active infection needing treatment or a history of tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: Dostarlimab and Niraparib treatment
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 it possible to enroll in the trial at this time?
"The clinicaltrials.gov website shows that this study is not recruiting patients at the moment. This trial was originally posted on December 15th, 2022 and last updated on October 3rd, 20222. Although this research isn't looking for volunteers currently, there are 2563 other trials which are actively recruiting right now."
Answered by AI
What are the known dangers of Niraparib?
"Niraparib's safety is rated as a 2 because, while there are Phase 2 trials underway testing its efficacy, there is no data yet supporting its use."
Answered by AI
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