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Carboplatin & Paclitaxel (CP) & Nivolumab

CP & Nivolumab: Carboplatin, Paclitaxel, Nivolumab

Regimen variant #1, 5/175/360

Study

Dates of enrollment

Evidence

Comparator

Comparative Efficacy

Forde et al. 2022 (CheckMate 816)


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2017-2019

Phase 3 (E-RT-esc)

1a. CP
1b. CVb
1c. DC

Superior EFS (co-primary endpoint)
Median EFS: 31.6 vs 20.8 mo
(HR 0.63, 97.38% CI 0.43-0.91)

Superior pCR rate (co-primary endpoint)
pCR rate: 24% vs 2.2%
(OR 13.94, 99% CI 3.49-55.75)

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.

Biomarker eligibility criteria

CheckMate 816: No sensitizing EGFR or ALK mutations

Cisplatin, Dacarbazine, Tamoxifen

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Rosenberg et al. 1999	1993-1997	Phase 3 (C)	Cisplatin, Dacarbazine, Tamoxifen, then IFN & IL-2	Did not meet primary endpoint of ORR

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.

Chemotherapy

Cisplatin (Platinol) 25 mg/m² IV over 30 minutes once per day on days 1 to 3
Dacarbazine (DTIC) 220 mg/m² IV over 60 minutes once per day on days 1 to 3

Endocrine therapy

Tamoxifen (Nolvadex) as follows:
- Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
- Cycle 2: 10 mg PO twice per day on days 1 to 8

21-day cycle for 2 cycles

References

Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. link to original article dosing details in manuscript have been reviewed by our editors PubMed