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Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma

ConditionsClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Recurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Paranasal Sinus Squamous Cell CarcinomaStage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Sinonasal Cancer AJCC v8Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Sinonasal Cancer AJCC v8Stage IVB Hypopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Lip and Oral Cavity Cancer AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Sinonasal Cancer AJCC v8Unresectable Head and Neck Squamous Cell CarcinomaUnresectable Hypopharyngeal Squamous Cell CarcinomaUnresectable Laryngeal Squamous Cell CarcinomaUnresectable Oral Cavity Squamous Cell CarcinomaUnresectable Oropharyngeal Squamous Cell CarcinomaUnresectable Paranasal Sinus Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

This phase I trial tests the safety, side effects, and best dose of camonsertib in combination with stereotactic body radiation therapy in controlling disease in patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that cannot be removed by surgery (unresectable). Camonsertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving camonsertib in combination with stereotactic body radiation therapy may help control disease in patients with recurrent or unresectable head and neck squamous cell cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have histologically confirmed recurrent or metachronous (second primary) unresectable head and neck squamous cell carcinoma involving the oral cavity, oropharynx, larynx, hypopharynx, and/or paranasal sinus, or cervical lymphadenopathy with unknown primary. Core needle biopsy (preferably at least three 18-gauge cores) or incisional biopsy is preferred over fine needle aspiration (FNA) for diagnosis of recurrent disease or new primary head and neck squamous cell carcinoma to provide sufficient tumor tissue for correlative studies. Unresectable refers both to patients who have declined surgery and patients deemed unresectable by otolaryngology. This includes patients for whom curative resection is medically contraindicated and/or would be associated with excessive surgical risk (as deemed by the consulting otolaryngologist) or undue surgical morbidity (e.g., total glossectomy, laryngectomy, and/or major resection requiring free flap reconstruction). There are no requirements related to prior systemic therapies that patients may have received

Patients must have recurrent disease within a previously irradiated area (radiotherapy to dose ≥ 30 gray [Gy] and ≤ 80 Gy; in-field recurrence)

Patients must have completed prior radiotherapy at least 6 months prior to enrollment. Due to safety concerns, reirradiation within less than 6 months to the head and neck is very rarely recommended per standard of care

Patients must have measurable disease (at least one measurable lesion) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Baseline imaging must include neck CT (preferably contrast-enhanced) and chest CT or skullbase to midthigh PET/CT (preferably with contrast-enhanced neck CT if diagnostic contrast-enhanced neck CT not available). Patients who have undergone surgery aside from biopsy may be included if gross disease is present within the surgical resection bed or at another site

Disqualifiers

Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1), with the exception of alopecia

Patients who are receiving any other investigational agents for a current cancer diagnosis

Patients with distant metastatic disease

Patients who have received more than one prior course of head and neck radiotherapy overlapping the region to be treated with the current diagnosis of head and neck cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Camonsertib

    Drug

    Given PO

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Stereotactic Body Radiation Therapy

    Radiation

    Undergo SBRT

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Treatment (camonsertib, SBRT)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

The safety and tolerability of camonsertib will be evaluated during the dose escalation phase. The frequency and percentage of AEs will be provided overall and by dose level for any grade and attribution as well as for grade 3 or greater AEs, at least possibly related to treatment.

Time frame
During dose escalation phase
2

Maximum tolerated dose (MTD) of camonsertib and concurrent stereotactic body radiation therapy (SBRT) reirradiation

The dose-escalation phase will utilize a Bayesian Optimal Interval Design to determine the MTD for combined camonsertib and SBRT.

Time frame
During dose escalation phase
3

Incidence of late toxicities (dose expansion phase)

The proportions of total patients experiencing late toxicities will be estimated. The frequency and percentage of AEs will be provided overall and by dose level for any grade and attribution as well as for grade 3 or greater AEs, at least possibly related to treatment.

Time frame
Within 1 year of treatment initiation

Secondary outcomes

1

Overall response rate

Will be evaluated within the radiation therapy field. Overall response will be defined as a complete or partial response based on the Response Evaluation Criteria in Solid Tumors 1.1 criteria. The proportion of patients responding to the treatment regimen and corresponding 95% confidence interval estimates will be calculated.

Time frame
Up to 55 weeks
2

Progression-free survival (PFS)

PFS will be estimated using the method of Kaplan-Meier.

Time frame
From the start of treatment regimen until documented local or distal failure or death from any cause, assessed up to 55 weeks

Other outcomes

1

Biomarkers of response

Time frame
Up to 55 weeks
2

Pharmacokinetic data

Time frame
Day 1: Pre, and 0.5, 1, 1.5, 2, 4, 6, and 8 hour post and Day 2: 24 hour after dose 1, pre-dose 2

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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