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A Phase 2, Randomized Study of Nivolumab (NIVO) and Ipilimumab (IPI) versus NIVO, IPI and Stereotactic Body Radiation Therapy (SBRT) for Metastatic Merkel Cell Carcinoma (MCC, NCT03071406) – a preliminary report.

Date

30 Sep 2019

Session

Poster Display session 3

Presenters

Sungjune Kim

Citation

Annals of Oncology (2019) 30 (suppl_5): v533-v563. 10.1093/annonc/mdz255

Authors

S. Kim1, N.I. Khushalani2, Z. Eroglu2, J. Russell3, E. Wuthrick4, J. Caudell4, L. Harrison4, M. Aoki4, H. Shah5, D. Blakaj6, J. Markowitz2, D. Chen7, J. Messina8, T. Rose9, K. Tsai8, A.S. Brohl2

Author affiliations

  • 1 Radiation Oncology & Immunology, H. Lee Moffitt Cancer Center University of South Florida, 33612 - Tampa/US
  • 2 Department Of Cutaneous Oncology, H. Lee Moffitt Cancer Center, 33612 - Tampa/US
  • 3 Oncology, Jansen, Philadelphia/US
  • 4 Department Of Radiation Oncology, H. Lee Moffitt Cancer Center, 33612 - Tampa/US
  • 5 Cutaneous Oncology, Ohio State University, Columbus/US
  • 6 Radiation Oncology, The Ohio State University James Cancer Hospital, 43210 - Columbus/US
  • 7 Department Of Bioinformatics And Biostatistics, H. Lee Moffitt Cancer Center, 33612 - Tampa/US
  • 8 Department Of Pathology, H. Lee Moffitt Cancer Center, 33612 - Tampa/US
  • 9 Department Of Radiology, H. Lee Moffitt Cancer Center, 33612 - Tampa/US
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Resources

Abstract 5715

Background

MCC is an aggressive cutaneous malignancy. Though checkpoint inhibitor therapy has dramatically improved the treatment landscape, outcome remains poor for those that are refractory to anti-PD1/PDL1 therapy. Combination checkpoint inhibition and the use of radiation therapy have been proposed as potentially synergistic interventions to improve immunotherapy (IT) response rates (RR).

Methods

In this multi-institutional trial, we enrolled patients (pts) with metastatic or recurrent MCC, ECOG PS 0-1, with at least 2 distinct metastatic lesions. Prior chemotherapy or immunotherapy was permitted. Primary endpoint was objective RR. In a randomized design of 2 experimental arms, pts received NIVO 240mg IV q2 wks plus IPI 1mg/kg IV q6 wks (arm A), or the same combination plus SBRT to 24Gy in 3 fractions between cycles 1 and 2 (arm B). Each arm uses a Simon Mini-Max two-stage design for futility, with total accrual of 50 assuming full accrual.

Results

To date, 16 pts have been enrolled, including 4 treatment-naïve and 12 PD1/PDL1-refractory pts. 11 pts were male and 5 pts female. Median age at enrollment was 75.5. On Arm A, the RR was 80% (1 CR, 3 PR) in 4/5 evaluable pts. On Arm B, the RR was 17% (1 PR) among 6 evaluable pts. 4 pts are pending initial staging and 1 pt expired prior to first evaluation. Collectively, 2/8 (25%) PD1/PDL1refractory pts and 3/3 (100%) IT-naïve pts have achieved CR/PR. 7 pts experienced > G2 immune toxicity (1 G3 myocarditis, 1 G3 colitis, 1 G2 arthritis, 1 G2 cough, 3 G2 dermatitis, 1 G2 neurotoxicity, 1 G2 blurred vision, 1 G2 abdominal pain, 2 G2 hypothyroidism, 1 G2 renal insufficiency). 1 pt was taken off the trial due to toxicity.

Conclusions

NIVO + IPI is safe and demonstrates promising initial efficacy in advanced MCC in both PD1/PDL1-naïve and refractory cases. SBRT can be safely added to this and its contribution to efficacy is being explored pending futility analysis. Arm A of the trial has already met efficacy criteria to proceed to full accrual.

Clinical trial identification

NCT03071406.

Editorial acknowledgement

Legal entity responsible for the study

H. Lee. Moffitt Cancer Center & Research Institute.

Funding

Bristol-Myers Squibb.

Disclosure

S. Kim: Research grant / Funding (institution), IIT funded through BMS rare malignancy program: BMS. N.I. Khushalani: Advisory / Consultancy: BMS. L. Harrison: Research grant / Funding (self): Viewray. All other authors have declared no conflicts of interest.

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