EUCTR2019-002986-36-IT
Active, not recruiting
Phase 1
A randomized, run-in, phase II study of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1 - NIBIT-ML-1
FONDAZIONE NIBIT NETWORK ITALIANO PER LA BIOTERAPIA DEI TUMORI0 sites184 target enrollmentAugust 3, 2021
ConditionsMM and NSCLC patients resistant to anti-PD-1/PD-L1 therapyMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MM and NSCLC patients resistant to anti-PD-1/PD-L1 therapy
- Sponsor
- FONDAZIONE NIBIT NETWORK ITALIANO PER LA BIOTERAPIA DEI TUMORI
- Enrollment
- 184
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Written Informed Consent
- •Willing and able to give written informed consent.
- •Target Population Subjects must fulfill all of the following inclusion criteria:
- •Men and women of and over 18 years old
- •1\) Target Population Melanoma cohort A
- •a) Histologic diagnosis of malignant melanoma
- •b) Unresectable Stage III/Stage IV melanoma patients with resistance to anti\-PD\-1/PD\-L1 and measurable lesions
- •by CT or MRI per iRECIST/RECIST criteria that can be amenable to biopsy
- •c) Only one line of immunotherapy for advanced (unresectable Stage III or Stage IV) disease with anti\-PD\-1/PDL1
- •and its combinations; if BRAF mutant one line of targeted therapy is allowed prior to anti\-PD\-1/PDL1therapy.
Exclusion Criteria
- •1\) Sex and Reproductive Status
- •a) Women who are pregnant or breastfeeding;
- •b) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- •and for up to 6 months after the study;
- •c) Women with a positive pregnancy test on enrollment or prior to investigational product administration;
- •d2\) Target Disease Exceptions
- •Nivolumab Ipilimumab Guadecitabine
- •NIBIT\-ML\-1 Clinical Protocol
- •a) Any malignancy from which the patient has been disease\-free for less than 2 years, with the exception of
- •adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ
Outcomes
Primary Outcomes
Not specified
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