Clinical trial · Interventional
Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma
A Randomized, Open Label, Multi-center Phase 2 Study of Nab-Paclitaxel Versus Epigenetic Modifying Therapy of CC-4386 With Nab-Paclitaxel in Subjects With Chemotherapy naïve Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic decision not to proceed with the opening of this study. There are no concerns over the safety or quality of the investigational products involved.
Summary
Brief summary (as posted)
A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abraxane 150 mg/m² Intravenous (IV)
- interventionNames
- Drug: Abraxane
- type
- EXPERIMENTAL
- label
- CC-486 orally plus Abraxane IV
- interventionNames
- Drug: Abraxane
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Up to 24 months
- description
- PFS is defined as the time from randomization date to disease progression according to RECIST response guideline
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 1\. Histologically or cytologically confirmed cutaneous BRAF wild-type malignant melanoma with evidence of metastasis (Stage IV).
2\. No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. No prior adjuvant cytotoxic chemotherapy is permitted.
* Up to one prior regimen with the following classes of agents is permitted:
o Targeted biologic agents (e.g. interleukin 2 \[IL-2\], granulocyte macrophage colony stimulating factor \[GM-CSF\], other cytokines or unarmed monoclonal antibodies)
o Targeted small molecule inhibitors (e.g., kinase inhibitors, heat shock protein \[HSP\] inhibitors, etc.).
* Immune checkpoint inhibitors (e.g. anti-CTLA4, anti-PD1, anti-PD-L1).
* Prior adjuvant therapy with interferon and/or vaccines is permitted.
* Prior treatments should be completed 4 weeks prior to enrollment in the study (ie, randomization).
3\. Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.
* If heterosexually active, the subject must agree to use medical doctor-approved contraception throughout the study, and for 6 months after last dose of study drug.
4\. History of malignancy in the last 5 years; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
* Subjects with other malignancies are eligible if they were cured by surgery (with or without radiotherapy) and have been continuously disease-free for at least 5 years.
5\. Radiographically-documented measurable disease (defined by the presence of at least one radiographically documented measurable lesion including measurable cutaneous metastasis).
6\. Adequate haemtological and biochemical parameters:
* ANC ≥ 1.5 x 109 cells/L.
* Platelets ≥ 100 x 109 cells/L.
* Hgb ≥ 9 g/dL.
* AST (SGOT) or ALT (SGPT) ≥ 2.5x upper limit of normal range (ULN);
o ≤ 5.0 x ULN if hepatic metastases present.
* Total bilirubin ≤ ULN. Creatinine ≤ 1.5 mg/dL. 8. ECOG performance status 0 to 1.
Exclusion Criteria:
* 1\. History of or current evidence of symptomatic brain metastases (brain Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) is needed to exclude brain metastasis), including leptomeningeal involvement.
2\. Subject has pre-existing peripheral neuropathy of National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.
3\. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.References
Publications (0)
Data not yet available