Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial

NCT05652673 | Recruiting DMC

• 1 other identifier: NL82177.078.22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab

Conditions

Melanoma Stage IV; Melanoma Stage III; Immunotherapy; Toxicity, Drug

Outcome Measures

Primary Outcomes (1)

• Ongoing response

  The rate of ongoing response at 12 months in patients with irresectable stage III or metastatic melanoma who are treated with first-line ipilimumab-nivolumab and who early discontinue nivolumab upon achieving a CR or PR according to RECIST v1.1

  12 months after start of ipilimumab-nivolumab combination therapy

Secondary Outcomes (10)

• Ongoing response

  24 months after start of treatment

• Disease control

  5 years after inclusion

• duration of response

  5 years after inclusion

• Melanoma Specific Survival rate

  5 years after inclusion

• Overall Survival

  5 years after inclusion

Study Arms (1)

Early discontinuation of nivolumab

EXPERIMENTAL

Drug: nivolumab

Interventions

nivolumab DRUG

Early discontinuation of nivolumab maintenance therapy in patients with irresectable stage III or metastatic melanoma

Early discontinuation of nivolumab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Irresectable stage III or metastatic melanoma
• Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab:
• previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed
• in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy.
• Response evaluation according to RECIST v1.1 30 using a diagnostic CT documenting target lesions every 12 (-2/+6) weeks from the start of ipilimumab-nivolumab:
• for patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed at baseline
• for patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST v1.1 criteria 30
• Patients should be included after first CR/PR or first confirmed CR/PR according to RECIST v1.1 30:
• no later than 9 months after start of treatment with ipilimumab-nivolumab
• Presence of MRI brain for the screening of brain metastases (prior to discontinuation of ipilimumab-nivolumab)
• Participants with previously locally treated brain metastases may participate in case they meet the following criteria:
• MRI of brain at baseline and for response evaluation during treatment
• Signed and dated informed consent form

You may not qualify if:

• Patients with SD/PD according to RECIST v1.1
• Presence of symptomatic brain metastases:
• prior to first-line treatment with ipilimumab-nivolumab, or;
• when defined as new or progressive brain metastases at the time of study entry;
• Presence of leptomeningeal metastases;
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3015GD, Netherlands

RECRUITING

Related Publications (1)

• Janssen JC, van Dijk B, de Joode K, Aarts MJB, van den Berkmortel FWPJ, Blank CU, Boers-Sonderen MJ, van den Eertwegh AJM, de Groot JWB, Jalving M, de Jonge MJA, Joosse A, Kapiteijn E, Kamphuis-Huismans AM, Naipal KAT, Piersma D, Rikhof B, Westgeest HM, Vreugdenhil G, Oomen-de Hoop E, Mulder EEAP, van der Veldt AAM. Safe Stop IPI-NIVO trial: early discontinuation of nivolumab upon achieving a complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab - study protocol. BMC Cancer. 2024 May 23;24(1):632. doi: 10.1186/s12885-024-12336-0.

  PMID: 38783238 DERIVED

MeSH Terms

Conditions

Melanoma; Drug-Related Side Effects and Adverse Reactions

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: December 15, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

NL (1)