OpACIN-neo

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

Multicenter Phase 2 Study to Identify of the Optimal Neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo)

Phase

Phase 2

Status

Unknown

Conditions

Malignant Melanoma Stage III

Interventions

Ipilimumab; Nivolumab; Surgery; Blood for PBMCs; Biopsies

Arms

• Arm A: 2 courses ipi 3 + nivo 1 · Experimental
• Arm B: 2 courses ipi 1 + nivo 3 · Experimental
• Arm C: 2 courses ipi 3 + 2 courses nivo 3 · Experimental
• PRADO extension cohort · Experimental

Enrollment

186

Primary outcomes

• Safety as measured by the frequency of grade 3/4 immune-related adverse events, using CTCAE 4.03
• Response rate according to RECIST 1.1
• Pathological response according to central pathological revision, according to pathological response criteria
• Pathologic response rate according to central revision of the marked index lymph node
• RFS at 24 months in patients achieving pCR or pnCR in their marked index lymph node and did not undergo CLND. RFS will be calculated from date of resection of the marked lymph node.
• RFS at 24 months in patients with pNR and being subsequently treated with adjuvant nivolumab+optional radiotherapy (or dabrafenib/trametinib if BRAFV600E pos. and treatment is approved). RFS will be calculated from day of resection of marked lymph node.

Sponsor

The Netherlands Cancer Institute with Bristol-Myers Squibb

Start

Nov 24, 2016

Primary completion

Jan 3, 2020

Results posted

No

Registry record

NCT02977052 · updated Nov 15, 2023

• Hoeijmakers LL, Dimitriadis P, Wijnen SCMA, Reijers ILM, Lopez-Yurda M, Menzies AM, Broeks A, Cornelissen S, Torres Acosta A, van der Wal A, Saw RPM, Versluis JM, van Houdt WJ, Wouters MW, Romano J, Rozeman EA, Grijpink-Ongering LG, Kapiteijn E, van der Veldt AAM, Suijkerbuijk KPM, Eriksson H, Hospers GAP, van der Hage JA, Grunhagen DJ, Witkamp AJ, Lijnsvelt JM, Klop WMC, Zuur CL, Bruining A, Al-Mamgani A, Pennington TE, Shannon KF, Ch'ng S, Colebatch AJ, Gonzalez M, Spillane AJ, Haanen JBAG, Rawson RV, Scolyer RA, van de Wiel BA, van Akkooi ACJ, Long GV, Blank CU. Neoadjuvant ipilimumab plus nivolumab in melanoma: 5-year survival and biomarker analysis from the phase 2 PRADO-trial. Nat Med. 2026 Mar;32(3):952-963. doi: 10.1038/s41591-025-04158-9. Epub 2026 Jan 28. PubMed 41606118
• Fraterman I, Reijers ILM, Dimitriadis P, Broeks A, Gonzalez M, Menzies AMM, Lopez-Yurda M, Kapiteijn E, van der Veldt AAM, Suijkerbuijk KPM, Hospers GAP, Long GV, Blank CU, van de Poll-Franse LV. Association between pretreatment emotional distress and neoadjuvant immune checkpoint blockade response in melanoma. Nat Med. 2023 Dec;29(12):3090-3099. doi: 10.1038/s41591-023-02631-x. Epub 2023 Nov 13. PubMed 37957378
• Hoefsmit EP, Vollmy F, Rozeman EA, Reijers ILM, Versluis JM, Hoekman L, van Akkooi ACJ, Long GV, Schadendorf D, Dummer R, Altelaar M, Blank CU. Systemic LRG1 Expression in Melanoma is Associated with Disease Progression and Recurrence. Cancer Res Commun. 2023 Apr 20;3(4):672-683. doi: 10.1158/2767-9764.CRC-23-0015. eCollection 2023 Apr. PubMed 37089863
• Zijlker LP, van der Burg SJC, Blank CU, Zuur CL, Klop WMC, Wouters MWMJ, van Houdt WJ, van Akkooi ACJ. Surgical outcomes of lymph node dissections for stage III melanoma after neoadjuvant systemic therapy are not inferior to upfront surgery. Eur J Cancer. 2023 May;185:131-138. doi: 10.1016/j.ejca.2023.03.003. Epub 2023 Mar 7. PubMed 36989829
• Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2. PubMed 36648215
• Reijers ILM, Menzies AM, van Akkooi ACJ, Versluis JM, van den Heuvel NMJ, Saw RPM, Pennington TE, Kapiteijn E, van der Veldt AAM, Suijkerbuijk KPM, Hospers GAP, Rozeman EA, Klop WMC, van Houdt WJ, Sikorska K, van der Hage JA, Grunhagen DJ, Wouters MW, Witkamp AJ, Zuur CL, Lijnsvelt JM, Torres Acosta A, Grijpink-Ongering LG, Gonzalez M, Jozwiak K, Bierman C, Shannon KF, Ch'ng S, Colebatch AJ, Spillane AJ, Haanen JBAG, Rawson RV, van de Wiel BA, van de Poll-Franse LV, Scolyer RA, Boekhout AH, Long GV, Blank CU. Personalized response-directed surgery and adjuvant therapy after neoadjuvant ipilimumab and nivolumab in high-risk stage III melanoma: the PRADO trial. Nat Med. 2022 Jun;28(6):1178-1188. doi: 10.1038/s41591-022-01851-x. Epub 2022 Jun 5. PubMed 35661157
• Versluis JM, Reijers ILM, Rozeman EA, Menzies AM, van Akkooi ACJ, Wouters MW, Ch'ng S, Saw RPM, Scolyer RA, van de Wiel BA, Schilling B, Long GV, Blank CU. Neoadjuvant ipilimumab plus nivolumab in synchronous clinical stage III melanoma. Eur J Cancer. 2021 May;148:51-57. doi: 10.1016/j.ejca.2021.02.012. Epub 2021 Mar 15. PubMed 33735809
• Rozeman EA, Hoefsmit EP, Reijers ILM, Saw RPM, Versluis JM, Krijgsman O, Dimitriadis P, Sikorska K, van de Wiel BA, Eriksson H, Gonzalez M, Torres Acosta A, Grijpink-Ongering LG, Shannon K, Haanen JBAG, Stretch J, Ch'ng S, Nieweg OE, Mallo HA, Adriaansz S, Kerkhoven RM, Cornelissen S, Broeks A, Klop WMC, Zuur CL, van Houdt WJ, Peeper DS, Spillane AJ, van Akkooi ACJ, Scolyer RA, Schumacher TNM, Menzies AM, Long GV, Blank CU. Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma. Nat Med. 2021 Feb;27(2):256-263. doi: 10.1038/s41591-020-01211-7. Epub 2021 Feb 8. PubMed 33558721
• Rozeman EA, Menzies AM, van Akkooi ACJ, Adhikari C, Bierman C, van de Wiel BA, Scolyer RA, Krijgsman O, Sikorska K, Eriksson H, Broeks A, van Thienen JV, Guminski AD, Acosta AT, Ter Meulen S, Koenen AM, Bosch LJW, Shannon K, Pronk LM, Gonzalez M, Ch'ng S, Grijpink-Ongering LG, Stretch J, Heijmink S, van Tinteren H, Haanen JBAG, Nieweg OE, Klop WMC, Zuur CL, Saw RPM, van Houdt WJ, Peeper DS, Spillane AJ, Hansson J, Schumacher TN, Long GV, Blank CU. Identification of the optimal combination dosing schedule of neoadjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma (OpACIN-neo): a multicentre, phase 2, randomised, controlled trial. Lancet Oncol. 2019 Jul;20(7):948-960. doi: 10.1016/S1470-2045(19)30151-2. Epub 2019 May 31. PubMed 31160251