A Phase II Study of the Combination of Ipilimumab and Fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma - NIBIT-M1

Conditions: Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma
MedDRA version: 9.1Level: LLTClassification code 10025670
MedDRA version: 9.1Level: LLTClassification code 10025671

Registration Number: EUCTR2010-019356-50-IT

Lead Sponsor: IBIT (NETWORK ITALIANO PER LA BIO-IMMUNOTERAPIA DEI TUMORI)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Signed Written Informed Consent a) Willing and able to give written informed consent. 2) Target Population a) Histologic diagnosis of malignant melanoma; b) Stage III (unresectable) or Stage IV melanoma; c) Maximum 1 line of chemotherapy for advanced disease allowed; d) No prior chemotherapy within 4 weeks from treatment start (6 weeks in case of nitrosourea); e) No previous systemic corticosteroid therapy within 10 days; f) Prior adjuvant treatment with IFN or other immunotherapy allowed; g) Asymptomatic brain metastases allowed; h) Measurable disease; i) Prior treatment of brain metastases. In case stereotactic radiotherapy (or surgery) was not applicable, whole brain radiotherapy should have been performed; j) Have a full set of baseline (ie, Screening) radiographic images, including, but not limited to: brain, chest, abdomen, pelvis and soft tissue and assessment of skin lesions. All images must be of adequate quality as detailed in Section 6.4; k) Life expectancy ? 16 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

4) Sex and Reproductive Status a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study; b) Women who are pregnant or breastfeeding; c) Women with a positive pregnancy test on enrollment or prior to investigational product administration; d) Sexually active fertile men not using effective birth control if their partners are WOCBP. 5) Target Disease Exceptions a) Any malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix; b) Primary ocular or mucosal melanoma. 6) Medical History and Concurrent Diseases a) Symptomatic brain metastases requiring immediate local intervention (radiotherapy (RT) and/or surgery); b) Autoimmune disease: Patients with a documented history of Inflammatory Bowel Disease, including ulcerative colitis and Crohn?s disease are excluded from this study as are patients with a documented history of symptomatic autoimmune disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener?s Granulomatosis] and autoimmune hepatitis. Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrom) are also excluded from this study; c) Any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea. 7) Prohibited Treatments and/or Therapies a) Concomitant therapy with any anti-cancer agent; immunosuppressive agents; any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month prior to or after any dose of study drug); surgery or radiotherapy (except as described in Sections 5.5.1 and 5.5.2); other investigational anti-cancer therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses); b) Previous treatment with other investigational products, including cancer immunotherapy, within 30 days; c) Previous enrollment in another clinical trial or prior treatment with a CD137 agonist or anti-CTLA-4 and/or fotemustine. 8) Other Exclusion Criteria a) Prisoners or subjects who are involuntarily incarcerated; b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.