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PD-1 Inhibitor

Niraparib + Dostarlimab for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Trisha Wise-Draper, MD, PhD

Research Sponsored by Trisha Wise-Draper

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options.

ECOG performance status ≤2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 3 years

Awards & highlights

Study Summary

This trial will test a new combo therapy for head and neck cancer to see if it is more effective than current treatments.

Who is the study for?

This trial is for adults with recurrent or metastatic non-cutaneous head and neck cancers (HNSCC) that can't be cured by surgery or radiation. Participants must be able to swallow pills, have a reasonable level of physical function (ECOG ≤2), and not have had severe side effects from previous cancer treatments, except hair loss. Those who've had both immunotherapy and PARP inhibitors, certain allergies, nasopharyngeal/salivary gland tumors, uncontrolled illnesses, or need high-dose steroids can't join.Check my eligibility

What is being tested?

The study tests the effectiveness of combining two drugs: Niraparib (a pill) and Dostarlimab (an injection), in patients with advanced HNSCC. The goal is to see how well this combination works in shrinking or controlling the cancer.See study design

What are the potential side effects?

Possible side effects include allergic reactions similar to those seen with other drugs like niraparib or dostarlimab; fatigue; digestive issues such as nausea; blood cell count changes leading to increased infection risk; skin reactions at injection sites; and hormonal imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My head or neck cancer has returned or spread and cannot be removed by surgery or cured with radiation.

Select...

I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response

Secondary outcome measures

Overall Survival

Progression Free Survival

Rate of all Adverse Events

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04409002

80%

Anemia

80%

Fatigue

73%

Abdominal pain

67%

CD4 lymphocytes decreased

67%

Alkaline phosphatase increased

67%

Nausea

60%

Anorexia

60%

Constipation

53%

Platelet count decreased

53%

Hyperglycemia

47%

Thromboembolic event

47%

Weight loss

47%

Anxiety

47%

Hypoalbuminemia

40%

Vomiting

40%

Peripheral motor neuropathy

40%

Blood bilirubin increased

40%

Dyspnea

40%

Hypertension

33%

Edema limbs

33%

Abdominal distension

33%

Aortic valve disease

33%

Back pain

33%

Diarrhea

33%

Fever

33%

Hypocalcemia

33%

Sinus tachycardia

27%

Depression

27%

White blood cell decreased

27%

Chills

27%

Ascites

27%

Hyponatremia

20%

Pain

20%

Urine discoloration

20%

Paresthesia

20%

Sore throat

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Insomnia

13%

Palpitations

13%

Thrush

13%

Pain in extremity

13%

Neutrophil count decreased

13%

Confusion

13%

Dehydration

13%

Fall

13%

Cardiac troponin T increased

13%

Alanine aminotransferase increased

13%

Aspartate aminotransferase increased

13%

Bloating

13%

Dry mouth

13%

Dysphagia

13%

Dysuria

13%

Flatulence

13%

Gastroesophageal reflux disease

13%

Glucosuria

13%

Hiccups

13%

Hypercalcemia

13%

Hyperkalemia

13%

Hypokalemia

13%

Hypophosphatemia

13%

Hypothyroidism

13%

Localized edema

Skin ulceration

Oral pain

Obesity

Oral hemorrhage

Encephalopathy

Generalized muscle weakness

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Osteoporosis

Urinary retention

Papulopustular rash

Skin infection

Endocarditis infective

Erectile dysfunction

Hematuria

Stroke

Thyroid stimulating hormone increased

Hemorrhoidal hemorrhage

Urinary frequency

Superficial thrombophlebitis

Tremor

Eye disorders - Other, specify

Pelvic pain

Prostatic obstruction

Pruritus

Rash acneiform

Rectal pain

Renal calculi

Reproductive system and breast disorders - Other, specify

Wheezing

Portal vein thrombosis

Vaginal dryness

Alopecia

Arthralgia

Arthritis

Bacteremia

Biliary tract infection

Blood lactate dehydrogenase increased

Buttock pain

Dry skin

Dysgeusia

Flank pain

Gastric anastomotic leak

Gastric ulcer

Gastritis

Gastrointestinal disorders - Other, specify

Gastrointestinal pain

Hyperlipidemia

Hypoglycemia

Lethargy

Memory impairment

Mucositis oral

Muscle cramp

Muscle weakness lower limb

Myocarditis

Restlessness

Scleral disorder

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Niraparib+Dostarlimab + Radiation

Trial Design

1Treatment groups

Experimental Treatment

Group I: Niraparib & DostarlimabExperimental Treatment2 Interventions

Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

FDA approved

Dostarlimab

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Trisha Wise-DraperLead Sponsor

5 Previous Clinical Trials

209 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,751 Previous Clinical Trials

8,067,449 Total Patients Enrolled

Trisha Wise-Draper, MD, PhD3.02 ReviewsPrincipal Investigator - University of Cincinnati

University of Cincinnati

4 Previous Clinical Trials

173 Total Patients Enrolled

1Patient Review

I would recommend avoiding this doctor if possible. She was very cold and had a nasty attitude. I don't think she knows what she's doing.

Media Library

Dostarlimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04313504 — Phase 2

Head and Neck Cancers Research Study Groups: Niraparib & Dostarlimab

Head and Neck Cancers Clinical Trial 2023: Dostarlimab Highlights & Side Effects. Trial Name: NCT04313504 — Phase 2

Dostarlimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04313504 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Dostarlimab a new investigational drug?

"At the moment, 112 clinical trials are underway to study Dostarlimab. Of these, 14 are in Phase 3. While many of the trials for Dostarlimab are located in Washington, District of Columbia, there are a total of 3147 locations operating trials for Dostarlimab around the world."

Answered by AI

How many test subjects are included in this research effort?

"That is correct, the trial detailed on clinicaltrials.gov appears to be ongoing with a posting date of November 4th, 2020 and last edit occurring on October 3rd, 2022. They are specifically looking for 23 individuals at 2 separate locations."

Answered by AI

What is the primary indication for Dostarlimab?

"Dostarlimab can be used to treat patients with primary peritoneal cancer, advanced mismatch repair-deficient (dmmr) endometrial cancer, and disease that has progressed during or following platinum-containing chemotherapy."

Answered by AI

Has the drug Dostarlimab been cleared for use by the FDA?

"Dostarlimab has received a score of 2 for safety. This is because, although there is data supporting its safety from Phase 2 trials, there is currently no evidence that the medication is effective."

Answered by AI

Are there any vacancies in this clinical trial for new participants?

"The study is still recruiting patients, as seen on clinicaltrials.gov. The posting date was November 4th 2020 with the most recent update being October 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

Trisha Wise-Draper 2020. "Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04313504.

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