NCT04576091

Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer

Active, enrolled Phase 1 Last updated 13 December 2024

What this trial tests

Phase 1 trial testing Biospecimen Collection in Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 in 7 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 July 2022

Primary endpoint
27 November 2024

11 December 2025

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	6 July 2022
Primary completion	27 November 2024
Estimated completion	11 December 2025
Sites	11 locations across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Computed Tomography
• Elimusertib — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Positron Emission Tomography
• Quality-of-Life Assessment
• Stereotactic Body Radiation Therapy — full drug profile →

Conditions studied

• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 — all drugs for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 →
• Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 — all drugs for Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 →
• Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck — all drugs for Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck →
• Recurrent Head and Neck Squamous Cell Carcinoma — all drugs for Recurrent Head and Neck Squamous Cell Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 or Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial evaluates the best dose, possible benefits and/or side effects of combination therapy with elimusertib (BAY 1895344), stereotactic body radiation, and pembrolizumab in treating patients with head and neck squamous cell cancer that has come back (recurrent) and cannot be removed by surgery (unresectable). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving BAY 1895344, stereotactic body radiation therapy in combination with pembrolizumab may shrink or stabilize head and neck squamous cell cancer for longer than treatment with radiation and immunotherapy without BAY 1895344.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiation-induced tumor immune microenvironments and potential targets for combination therapy.
   Guo S, Yao Y, Tang Y, Xin Z, et al · · 2023 · cited 136× · PMID 37208386 · DOI 10.1038/s41392-023-01462-z
2. Leveraging the replication stress response to optimize cancer therapy.
   Cybulla E, Vindigni A. · · 2023 · cited 109× · PMID 36323800 · DOI 10.1038/s41568-022-00518-6
3. A new wave of innovations within the DNA damage response.
   Li Q, Qian W, Zhang Y, Hu L, et al · · 2023 · cited 85× · PMID 37679326 · DOI 10.1038/s41392-023-01548-8
4. Targeting the replication stress response through synthetic lethal strategies in cancer medicine.
   Ngoi NYL, Pham MM, Tan DSP, Yap TA. · · 2021 · cited 78× · PMID 34215565 · DOI 10.1016/j.trecan.2021.06.002
5. Therapeutic strategies of different HPV status in Head and Neck Squamous Cell Carcinoma.
   Sun Y, Wang Z, Qiu S, Wang R. · · 2021 · cited 43× · PMID 33867833 · DOI 10.7150/ijbs.58077
6. Emerging strategies for cancer therapy by ATR inhibitors.
   Yano K, Shiotani B. · · 2023 · cited 42× · PMID 37189251 · DOI 10.1111/cas.15845
7. Key Proteins of Replication Stress Response and Cell Cycle Control as Cancer Therapy Targets.
   Khamidullina AI, Abramenko YE, Bruter AV, Tatarskiy VV. · · 2024 · cited 34× · PMID 38279263 · DOI 10.3390/ijms25021263
8. Targeting the DNA damage response for cancer therapy.
   Curtin NJ. · · 2023 · cited 30× · PMID 36606678 · DOI 10.1042/bst20220681