NCT03798639

Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer

Completed Phase 1 Last updated 12 April 2024

What this trial tests

Phase 1 trial testing Ipilimumab in Merkel Cell Carcinoma in 7 participants. Completed in 2 December 2022.

Timeline

7 January 2019

Primary endpoint
2 December 2022

2 December 2022

Quick facts

Lead sponsor	Claire Verschraegen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	7 January 2019
Primary completion	2 December 2022
Estimated completion	2 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Ipilimumab — full drug profile →
• Nivolumab (nivolumab) — full drug profile →
• Radiation Therapy — full drug profile →

Conditions studied

• Merkel Cell Carcinoma — all drugs for Merkel Cell Carcinoma →
• Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8 — all drugs for Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8 →
• Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8 — all drugs for Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8 →

Sponsor

Claire Verschraegen

Who can join

18 and older, any sex, with Merkel Cell Carcinoma or Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and how well nivolumab works when given together with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons or other sources to kill tumor cells and shrink tumors. Giving nivolumab with radiation therapy or ipilimumab after surgery may kill any remaining tumor cells.

Publications & conference data

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

1. Non-Melanoma Skin Cancers: Biological and Clinical Features.
   Cives M, Mannavola F, Lospalluti L, Sergi MC, et al · · 2020 · cited 120× · PMID 32751327 · DOI 10.3390/ijms21155394
2. Immunotherapy for Non-melanoma Skin Cancer.
   Shalhout SZ, Emerick KS, Kaufman HL, Miller DM. · · 2021 · cited 64× · PMID 34448958 · DOI 10.1007/s11912-021-01120-z
3. Merkel Cell Carcinoma: New Trends.
   Zwijnenburg EM, Lubeek SFK, Werner JEM, Amir AL, et al · · 2021 · cited 31× · PMID 33807446 · DOI 10.3390/cancers13071614
4. Landscape and Future Perspectives of Immunotherapy in Neuroendocrine Neoplasia.
   Maggio I, Manuzzi L, Lamberti G, Ricci AD, et al · · 2020 · cited 30× · PMID 32235636 · DOI 10.3390/cancers12040832
5. Immune Checkpoint Inhibition in Non-Melanoma Skin Cancer: A Review of Current Evidence.
   Stonesifer CJ, Djavid AR, Grimes JM, Khaleel AE, et al · · 2021 · cited 25× · PMID 34988009 · DOI 10.3389/fonc.2021.734354
6. Immunotherapies in rare cancers.
   Vivekanandhan S, Bahr D, Kothari A, Ashary MA, et al · · 2023 · cited 24× · PMID 36726126 · DOI 10.1186/s12943-023-01720-2
7. Identifying Candidates for Immunotherapy among Patients with Non-Melanoma Skin Cancer: A Review of the Potential Predictors of Response.
   Zelin E, Maronese CA, Dri A, Toffoli L, et al · · 2022 · cited 24× · PMID 35743435 · DOI 10.3390/jcm11123364
8. Merkel Cell Carcinoma.
   Dellambra E, Carbone ML, Ricci F, Ricci F, et al · · 2021 · cited 24× · PMID 34201709 · DOI 10.3390/biomedicines9070718