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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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).