Immunotherapy Clinical Trial
Official title:
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
Verified date | September 2023 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 1, 2029 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 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 - in case of asymptomatic brain metastases prior to start of first-line ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an MRI for response evaluation prior to inclusion in this study. - Patients should be included after first CR/PR or first confirmed CR/PR according to RECIST v1.1 30: - inclusion should take place no later than 5 weeks after first confirmed CR/PR - in case of SD at first response evaluation, confirmed CR/PR is required for inclusion - planned and willing to discontinue nivolumab within 4(+1) weeks after inclusion, i.e. first CR/PR or first confirmed CR/PR - 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: - completely asymptomatic brain metastases at inclusion - MRI of brain at baseline and for response evaluation during treatment - Signed and dated informed consent form Exclusion Criteria: - Patients with SD/PD according to RECIST v1.1 - Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ. - 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; - brain metastases with need for steroid treatment in the last 8 weeks prior to study entry Note: An incidental epileptic seizure caused by a brain lesion is not considered an exclusion criterion. (provided that the other in- and exclusion criteria are met); - Presence of leptomeningeal metastases; - Systemic chronic steroid therapy (>10mg/day prednisone or equivalent) at inclusion or patients who need or needed any other second-line immunosuppressive therapy (e.g. infliximab, mycophenolate mofetil) for the treatment of immune related adverse events (irAEs). Note: local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed. - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus MC | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Ongoing response | Ongoing response at 24 months after start of first-line treatment with ipilimumab-nivolumab | 24 months after start of treatment | |
Secondary | Disease control | Disease control (CR/PR) at different time points | 5 years after inclusion | |
Secondary | duration of response | Duration of response (CR/PR) measured until progressive/recurrent disease | 5 years after inclusion | |
Secondary | Melanoma Specific Survival rate | Melanoma specific survival measured from start of first-line treatment with ipilimumab-nivolumab until melanoma related death | 5 years after inclusion | |
Secondary | Overall Survival | Overall survival (OS) measured from start of first-line treatment with ipilimumab-nivolumab until death by any cause | 5 years after inclusion | |
Secondary | (serious) adverse events | Impact of discontinuation treatment on (S)AEs | 5 years after inclusion | |
Secondary | ORR | Overall Response Rate (ORR) per RECIST v1.1 in retreated patients | 5 years after inclusion | |
Secondary | Re-treatment | Rate of re-treatment for melanoma | 5 years after inclusion | |
Secondary | Disease control (CR/PR/SD [stable disease]/not PD [progressive disease]) after restarting (systemic) treatment for melanoma | Disease control (CR/PR/SD [stable disease]/not PD [progressive disease]) after restarting (systemic) treatment for melanoma | 5 years after inclusion | |
Secondary | Quality of life questionnaires EuroQoL EQ-5D-5 | Quality of life is measured using questionnaires: EuroQoL EQ-5D-5 | 5 years after inclusion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05848011 -
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05161572 -
Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT06165900 -
Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
|
Phase 2 | |
Recruiting |
NCT06120127 -
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
|
Phase 2 | |
Recruiting |
NCT06262581 -
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
|
Phase 2 | |
Recruiting |
NCT05176002 -
Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05909137 -
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
|
||
Recruiting |
NCT04500990 -
MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
|
||
Not yet recruiting |
NCT04372732 -
Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
|
||
Completed |
NCT02692976 -
Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients
|
Phase 2 | |
Completed |
NCT03763630 -
MAPS & ITEC Cohorts: 6-8 Years Follow-up
|
Phase 2 | |
Not yet recruiting |
NCT06012318 -
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
|
||
Not yet recruiting |
NCT05479240 -
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer
|
Phase 2 | |
Recruiting |
NCT04711330 -
Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
|
||
Recruiting |
NCT05515796 -
Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors
|
Phase 2 | |
Recruiting |
NCT03683407 -
Effect of Chemotherapy on TMB in NSCLC
|
||
Recruiting |
NCT03701607 -
Effect of Chemotherapy on PD-L1 in NSCLC
|
||
Completed |
NCT03357861 -
Cancer Patients Treated With Immunotherapy in Intensive Care Unit
|
||
Recruiting |
NCT05223088 -
Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer
|
Phase 2 | |
Completed |
NCT05657262 -
Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas
|
N/A |