Phase 3
Completed N=269
Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma
Melanoma · Recurrent Melanoma
Source: ClinicalTrials.gov NCT01359956 ↗
Enrolled (actual)
269
Serious AEs
23.4%
Results posted
Nov 2020
Primary outcomePrimary: Overall Survival (OS) — 7.9; 8.6; 9.1; 7.7 Months
◆ Published Evidence
Established
25citations · ~2 / year
Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-α in advanced malignant melanoma.
Summary
This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.
Linked Publications
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Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-α in advanced malignant melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
7.9; 8.6; 9.1; 7.7 | — |
| SECONDARY Progression Free Survival (PFS) |
2.7; 2.5; 2.8; 2.5 | — |
| SECONDARY Overall Response Rate (ORR) |
32; 33; 34; 31 | — |
| SECONDARY Treatment Related Toxicity |
129; 122; 119; 132 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy.
- Presence of measurable disease
- Age > or = 18 years and 3 weeks from initiating .
- If palliative radiation is needed, in case of non target lesions, it must be given prior to initiating chemotherapy. If palliative radiation is required during the study the patient should be permanently discontinued from further treatment.
- Adequate contraceptive measures during study participation for sexually active patients of child bearing potential must implement.
Exclusion Criteria
- Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
- Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)
- Known HIV disease.
- Concurrent treatment with other experimental drugs.
- Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
- Pregnant or lactating females Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) Known HIV disease. Concurrent treatment with other experimental drugs. Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
Data sourced from ClinicalTrials.gov (NCT01359956) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.