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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
STAR Trial 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.Check my eligibility
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.See study design
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.
STAR Trial 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.
Select...
I can take pills by mouth.
Select...
My cervical cancer has come back or gotten worse.
Select...
I have had at least one treatment that went through my whole body.
Select...
I am a woman and I am 18 years old or older.
Select...
I am fully active or can carry out light work.
STAR Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with response to treatment
Secondary outcome measures
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%
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%
Back pain
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
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%
Postnasal drip
4%
Hypokalemia
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
STAR 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
~1540
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,547 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what conditions is Niraparib typically prescribed?
"Niraparib is widely prescribed for primary peritoneal cancer and other related conditions, like advanced dmmr endometrial cancer that has progressed following platinum-based chemotherapy, as well as fallopian tube carcinoma."
Answered by AI
Can you tell me about any additional investigations that have been conducted with Niraparib?
"In 2010, City of Hope inaugurated the testing of niraparib. Since then 17 trials have been completed and there are currently 115 active studies being conducted in Oklahoma City, Oklahoma."
Answered by AI
Is there an opportunity at present for participants to join this clinical trial?
"Clinicaltrials.gov affirms that this study is currently accepting participants; the trial was initially advertised on February 26th 2020, and most recently amended on November 21st 2022."
Answered by AI
How many participants are currently engaging in the experiment?
"Affirmative. According to the medical data posted on clinicaltrials.gov, this experiment is currently in search of participants and was initially published on February 26th 2020 with a recent update on November 21st 2022. 66 individuals are needed from two different locations for enrolment purposes."
Answered by AI
How much risk do patients face when taking Niraparib?
"Our team has determined that Niraparib is moderately safe, as evidenced by its score of 2. This evaluation takes into account the preliminary safety data from the phase 2 trial and lack of evidence for efficacy."
Answered by AI
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