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Monoclonal Antibodies
Niraparib + Dostarlimab for Recurrent Cervical Cancer (STAR Trial)
Phase 2
Recruiting
Led By Debra Richardson, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has archival tumor tissue available or a fresh biopsy of recurrent or persistent tumor must be obtained prior to study treatment initiation
Patient is able to take oral medications
Must not have
Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
Major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of a new cancer treatment combination and its effects on patients with cervix cancer.
Who is the study for?
This trial is for women aged 18+ with recurrent or progressive cervical cancer who have had at least one systemic treatment (excluding chemo with radiation). They must have measurable lesions, stable corticosteroid doses if applicable, good organ function, and an ECOG status of 0-1. Exclusions include active CNS metastases, recent transfusions, certain blood disorders, HIV/Hepatitis B/C infections, recent investigational drug use or major surgery.
What is being tested?
The study tests the safety and effects of combining Niraparib and dostarlimab in treating cervical cancer that has come back or worsened. Participants will receive both drugs to determine how well they work together against this type of cancer.
What are the potential side effects?
Potential side effects may include fatigue, nausea, digestive issues from Niraparib; immune-related reactions like skin rash or thyroid problems from dostarlimab. Side effects can vary widely among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide samples of my tumor for the study.
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I can take pills by mouth.
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My cervical cancer has come back or gotten worse.
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I have had at least one treatment that went through my whole body.
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I am a woman and I am 18 years old or older.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious illnesses or infections that are not under control.
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I had major surgery less than 3 weeks ago but have recovered from it.
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I haven't had certain cancer treatments or radiation affecting a lot of bone marrow recently.
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I have a history of lung scarring or fibrosis.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have been diagnosed with HIV.
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I have not received any colony stimulating factors in the last 4 weeks.
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I have a history of MDS or AML.
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I have active hepatitis B or C.
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I am allergic to niraparib or Dostarlimab or their ingredients.
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I have been treated with a PARP inhibitor before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of patients with response to treatment
Secondary study objectives
Duration of patients with response
Number of patients who experience toxicity
Overall survival
+1 moreSide effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dizziness
22%
Insomnia
22%
Dyspnea
22%
Abdominal pain
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Urinary tract infection
9%
Cough
9%
Dehydration
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Postnasal drip
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Peripheral sensory neuropathy
4%
Hyperkalemia
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Skin tear
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Bruising
4%
Esophageal ulcer
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Upper respiratory infection
4%
Leukocytosis
4%
White blood cell decreased
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
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: Niraparib + dostarlimabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~2400
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,615 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,490 Total Patients Enrolled
Debra Richardson, MDPrincipal InvestigatorStephenson Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 14 days.I have not had active treatment for another cancer, except skin cancer, in the last 2 years.I have not been in a clinical trial for a new treatment or device within the last 4 weeks.I agree not to donate blood during the study or for 90 days after the last treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I do not have any serious illnesses or infections that are not under control.I had major surgery less than 3 weeks ago but have recovered from it.I haven't had certain cancer treatments or radiation affecting a lot of bone marrow recently.I have a history of lung scarring or fibrosis.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have stable brain metastases and haven't used steroids in the last 7 days.I have been diagnosed with HIV.I can provide samples of my tumor for the study.I have not received any colony stimulating factors in the last 4 weeks.I still have side effects from chemotherapy, but my nerve pain is mild and I may have moderate hair loss.I can take pills by mouth.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.My organs are functioning well.I had a severe reaction to previous immunotherapy, except for minor lab changes.I have a history of MDS or AML.I have been on a stable dose of corticosteroids for at least 4 weeks.My cervical cancer has come back or gotten worse.I have had at least one treatment that went through my whole body.I am a woman and I am 18 years old or older.I received a blood transfusion within the last 4 weeks.I have had severe blood issues from recent chemo that lasted more than 4 weeks.I have active hepatitis B or C.I am allergic to niraparib or Dostarlimab or their ingredients.I have been treated with a PARP inhibitor before.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Niraparib + dostarlimab
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.
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