Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer

NCT04220775 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 2019-0608NCI-2019-07625
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/II trial studies the side effects and how well bintrafusp alfa and stereotactic body radiation therapy work in treating patients with head and neck squamous cell cancer that has come back (recurrent) or has occurred after having cancer in the past (second primary). Immunotherapy with bintrafusp alfa may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving bintrafusp alfa and stereotactic body radiation therapy may help to control recurrent head and neck squamous cell cancer.

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma; Second Primary Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity (DLT)

  For the phase I part of this phase I/II study, the primary endpoint was DLT defined as any grade 3 or above AE resulting in inability to complete radiotherapy due to toxicity related to M7824 or the combination of M7824 and SBRT.

  The DLT window is from first M7824 dose (D0) until 14 days post SBRT (D28).

Secondary Outcomes (8)

• Progression-free Survival (PFS) Rate at 1 Year

  Up to 1 year

• Overall Response by RECIST

  Tumor reassessment during treatment

• Overall Survival (OS)

  Up to 1 year

• To Evaluate Acute and Late Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE)-v5.0

  Up to 1 year

• To Evaluate Fibrosis-related Toxicities and Functional Outcomes

  up to 1 year

Study Arms (1)

Treatment (bintrafusp alfa, SBRT)

EXPERIMENTAL

Patients receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 15 of cycle 1, patients also undergo SBRT over 5 fractions once QOD for 2 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Bintrafusp Alfa; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Interventions

Bintrafusp Alfa DRUG

Given IV

Also known as: Anti-PDL1/TGFb Trap MSB0011359C, M7824, MSB0011359C

Treatment (bintrafusp alfa, SBRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (bintrafusp alfa, SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (bintrafusp alfa, SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (bintrafusp alfa, SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically documented local-regional recurrent squamous cell carcinoma of the head and neck, or second primary squamous cell carcinoma of the head and neck
• Patients must be willing to undergo research biopsy for tissue collection at baseline and at disease progression
• Previous receipt of at least 30 Gy of radiation for head and neck squamous cell cancer (HNSCC) with overlapping fields
• Not eligible or poor candidate or patient refusal of surgery for recurrence
• Evaluable disease apparent on imaging (MRI or computed tomography \[CT\])
• to 3 sites of recurrence (\< 60 cm\^3 per site, total volume \< 100 cm\^3)
• Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
• White blood count (WBC) \>= 2000/L
• Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
• Platelets \>= 100,000 cells/mm\^3
• Hemoglobin \>= 9.0 g/dl; Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) \>= 9.0 g/dl is acceptable
• Serum creatinine =\< 1.5 mg/dl or creatinine clearance (CC) \>= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except patients with Gilbert syndrome who can have total bilirubin \< 3.0 mg/dL)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 x the upper limit of normal
• Negative serum pregnancy test for women of childbearing potential and confirmation within 24 hours of first dose of study drug

You may not qualify if:

• Presence of distant metastases
• Less than six-month disease free interval from end of prior radiotherapy to the head and neck
• Prior receipt of anti-PD-1/L1
• Patients who are pregnant or breast feeding
• Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device; myocardial infarction within 3 months of registration
• Active autoimmune disorder or immunosuppression (including human immunodeficiency virus \[HIV\], but excluding endocrine abnormalities that are controlled with replacement medications)
• Active viral hepatitis
• Steroid therapy of greater than prednisone 10 mgs a day or equivalent
• Prior history of invasive non-head and neck cancer within two years, with the exception of screen detected prostate cancer treated with observation only, basal cell and squamous cell carcinoma of the skin, and micro-invasive resected cervical carcinoma

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Saint A, Van Obberghen-Schilling E. The role of the tumor matrix environment in progression of head and neck cancer. Curr Opin Oncol. 2021 May 1;33(3):168-174. doi: 10.1097/CCO.0000000000000730.

  PMID: 33720067 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

bintrafusp alfa protein, human; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Renata Ferrarotto
• Organization: M D Anderson Cancer Center

rferrarotto@mdanderson.org

(713) 745-6774

Study Officials

• Renata Ferrarotto

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: January 7, 2020
• Study Start: March 18, 2020
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: November 7, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-07

Locations

US (1)