A Single-arm Phase II Trial of Palliative "QUAD SHOT" Radiotherapy Combined With Pembrolizumab in Patients With Recurrent Head & Neck Cancer
Overview
- Phase
- Phase 2
- Intervention
- Pebrolizumab + QUADSHOT Radiotherapy
- Conditions
- Head and Neck Cancer
- Sponsor
- University of Oklahoma
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Tumor Response Rate
- Status
- Active, Not Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The purpose of this study is to test the safety of palliative "QUAD SHOT" radiotherapy combined with pembrolizumab and evaluate the effects of the combination treatment patients with recurrent cancer of head and neck.
Detailed Description
During this study, patients will receive infusions of pembrolizumab with radiotherapy (palliative QUADSHOT regimen). The patient will receive treatment of pembrolizumab once every 3 weeks and palliative "QUAD SHOT" radiotherapy every 4 weeks. These 28 day period of time is called a cycle. The cycle will be repeated 3 times. Each cycle is numbered in order. The patient will be treated for up to 3 cycles followed by pembrolizumab single drug until unacceptable toxicity or tumor progression. The patient will also complete a survey. Total duration of the study is up to two years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years and older
- •Written informed consent and any locally-required authorization obtained from the patients prior to performing any protocol-related procedures, including screening evaluations
- •Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary).
- •Locally recurrent or metastatic HNSCC not deemed amenable to curative-intent salvage therapy, in whom at least six months have passed since their prior RT, if received.
- •Must have evaluable lesion per RECIST v1.1
- •Patients agree to provide their smoking history prior to registration
- •ECOG performance status of 0-2
- •Adequate bone marrow: absolute neutrophil count ≥ 1,500/μl, platelets ≥ 100,000/μl, hemoglobin ≥ 9 g/dL
- •Adequate hepatic function: total bilirubin ≤ 1.5 X upper normal limit (UNL) (except subjects with Gilbert syndrome, who can have total bilirubin \< 3 mg/dl), aspartate aminotransferase (AST) ≤ 2.5 X UNL, alanine aminotransferase (ALT) ≤ 2.5 X UNL
- •Adequate renal function: calculated serum creatinine clearance \>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection or Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)
Exclusion Criteria
- •Histologically confirmed other types (Non-SCC) of salivary gland cancer
- •History of another primary malignancy EXCEPT For:
- •malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence;
- •adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease (eg, carcinoma in situ of the breast, oral cavity and cervix are all permissible);
- •low to favorable intermediate risk prostate cancer based on NCCN criteria on active surveillance, .
- •Prior radiotherapy to the region of the study cancer within less than 6 months
- •Patients who have received prior radiation therapy and who, in the opinion of the treating radiation oncologist, cannot be reirradiated safely without excess risk of severe toxicity given prior radiation dose to critical structures.
- •Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia-Telangiectasia, Nijmegen Breakage Syndrome)
- •Patients with inadequate renal function or other contraindications to IV contrast
- •Any previous treatment with PD-1 or PD-L1 inhibitors, including pembrolizumab
Arms & Interventions
Pembrolizumab + QUADSHOT Radiotherapy
Combination Treatment * Pembrolizumab by IV once on day 1 of 21 day cycle, begin 7 days before the first round of QUAD SHOT radiotherapy. * QUAD SHOT radiotherapy twice a day for two days, begin 7 days after the first dose of pembrolizumab; repeat every 28 days for up to 3 rounds. Maintenance Treatment * Pembrolizumab by IV once on day 1 of 21 day cycle * On day 21, if the medical oncologist feels that the patient may safely continue treatment, patient will receive a new 21 days cycle of treatment with pebrolizumab.
Intervention: Pebrolizumab + QUADSHOT Radiotherapy
Outcomes
Primary Outcomes
Tumor Response Rate
Time Frame: up to 2 years
Health-Related Quality of Life Questionnaire
Time Frame: up to 2 years
Secondary Outcomes
- Overall Survival(up to 2 years)
- Progression Free Survival(12 months)
- Incidence of post treatment toxicities(up to 2 years)
- Duration of Response(up to 2 years)