T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma (NCT05756556) | Clinical Trial Compass
SuspendedPhase 2
T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma
Stopped: Change in drug development and lifecycle management and decide to suspend this study
United States68 participantsStarted 2024-06-30
Plain-language summary
This study will evaluate the efficacy and safety of T3011 in combination with Cobimetinib in patients with advanced melanoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient has provided informed consent prior to initiation of any study-specific activities/procedures.
✓. Male or female age ≥ 18 years at the time of informed consent.
✓. Willingness to provide pre-and post-treatment fresh tumor biopsy specimens as specified in the Schedule of Study Procedures and Assessments (Table 1).
✓. Histologically confirmed diagnosis of malignant melanoma (except for uveal melanoma).
✓. Patient with stage IIIB to IV advanced malignant melanoma (as defined by American Joint Committee on Cancer \[AJCC\] staging manual version 8.0) that is not surgically resectable, failed for standard of care (SOC) therapy or in the opinion of the investigator not suitable for SOC therapy. SOC may include, but not be limited to chemotherapy, targeted therapy or immunotherapy.
✓. BRAF V600E/V600K mutation-positive (applied to part 1 and part 2 cohort 1) or RAS mutation-positive (applied to part 1 and part 2 cohort 2). BRAF V600E/V600K and RAS mutation status result from diagnosis of tumor histopathology should be provided during Screening. If the patient is unable to provide, testing will be required during the Screening period in local laboratory.
✓. Measurable disease defined as one or both of the following:
✓. At least 1 injectable melanoma lesion ≥ 5 mm in longest diameter, or in the opinion of the investigator the lesion can be injected.
Exclusion criteria
✕. Prior treatment with other Oncolytic virus (OV) (including but not be limited to T-VEC), tumor vaccines, cellular therapy or gene therapy.
What they're measuring
1
ORR
Timeframe: up to 5 years after the first dose of the last patient, depending on the actual situation.
2
Characterize the safety and tolerability of T3011 in combination with Cobimetinib.
Timeframe: up to 5 years after the first dose of the last patient, depending on the actual situation.
✕. Prior local anti-tumor therapy \< 21 days prior to the first dose of study treatment; prior systemic targeted therapy (including but not be limited to MEK inhibitors) \< 21 days or last dose of therapy with MEK inhibitors \< 5 times the half-life prior to first dose of study treatment; prior other anti-tumor therapy (including but not be limited to PD-1/programmed cell death ligand 1\[PD-L1\]) \< 21 days prior to the first dose of study treatment, prior major surgery \< 21 days prior to the first dose of study treatment.
✕. Prior treatment with anti-PD-(L)1 monoclonal Ab in combination with IL-12.
✕. Previous intolerance to anti-PD-(L)1 monoclonal Ab or previous history of immunotherapy induced ≥ NCI CTCAE version 5.0 Grade 3 non-infectious pneumonitis/interstitial lung disease.
✕. The following foods/supplements are used within 7 days before the study treatment or the following foods/supplements are planned to be used during the study treatment:
✕. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection).
✕. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
✕. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).