What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, particularly those involving PD-1 inhibitors like dostarlimab and PARP inhibitors like niraparib, are associated with a range of side effects. PD-1 inhibitors often lead to immune-related adverse events such as skin reactions (rash, pruritus), endocrine disorders (hypothyroidism), and gastrointestinal issues (diarrhea). PARP inhibitors typically cause hematologic toxicities (anemia, thrombocytopenia) and non-hematologic side effects like nausea and fatigue. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Pembrolizumab and Nivolumab, both PD-1 inhibitors, have received FDA approval for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Pembrolizumab is approved for use in patients with high PD-L1 expression, either as a monotherapy or in combination with chemotherapy. Nivolumab is approved for previously treated HNSCC patients. While there is no specific mention of FDA-approved PARP inhibitors for HNSCC, Niraparib is currently being studied in combination with Dostarlimab, a PD-1 inhibitor, for this indication.

What other types of research exist?

Promising alternatives for head and neck cancer treatment in 2024 include pembrolizumab plus cetuximab, which has shown a 45% overall response rate in treatment-refractory metastatic cases. Additionally, metronomic chemotherapy, which uses frequent, lower doses of chemotherapy to target tumor angiogenesis, is being investigated as a novel approach. Farnesyltransferase inhibitors like tipifarnib have also demonstrated encouraging response rates in HRAS mutant squamous cell carcinoma of the head and neck.

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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

Must not have

Nasopharyngeal and salivary gland tumors

Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 3 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, dostarlimab and niraparib, in patients with head and neck cancer that has come back or spread. Dostarlimab helps the immune system attack cancer, while niraparib prevents cancer cells from repairing themselves. Niraparib is an oral drug approved for maintenance treatment in ovarian, fallopian tube, or primary peritoneal cancer.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer is in the nasopharynx or salivary glands.

Select...

I am not taking more than 10mg of steroids daily.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response

Secondary study objectives

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%

Paresthesia

20%

Pain

20%

Sore throat

20%

Urine discoloration

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Neutrophil count decreased

13%

Thrush

13%

Insomnia

13%

Palpitations

13%

Pain in extremity

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 infection

Hematuria

Stroke

Oral pain

Superficial thrombophlebitis

Urinary retention

Tremor

Obesity

Thyroid stimulating hormone increased

Hemorrhoidal hemorrhage

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

Erectile dysfunction

Skin ulceration

Urinary frequency

Generalized muscle weakness

Papulopustular rash

Oral hemorrhage

Osteoporosis

Encephalopathy

Endocarditis infective

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

PD-1 inhibitors, such as Dostarlimab, enhance the immune system's ability to fight cancer by blocking the PD-1 pathway, which cancer cells use to avoid immune detection. PARP inhibitors, like Niraparib, prevent cancer cells from repairing their DNA by inhibiting the PARP enzyme, leading to cell death. These targeted treatments are significant for Head and Neck Cancer patients as they provide new avenues for therapy, especially in cases where conventional treatments have been ineffective.

Prognostic and Predictive Factors in Advanced Head and Neck Squamous Cell Carcinoma.Synergistic Growth Inhibition by Afatinib and Trametinib in Preclinical Oral Squamous Cell Carcinoma Models.Direct inhibition of STAT signaling by platinum drugs contributes to their anti-cancer activity.