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A Phase Ib/II Study of APG-115 in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors
Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors. Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas.
Irina Geier at email@example.com
18 year(s) or older
Inclusion Criteria:Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent
Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD1 antibody treatment and ineligible for other standard of care therapy
ECOG Performance scale of 0-2
Life expectancy of equal to or greater than 3 months
Adequate bone marrow and organ functionAdequate
Exclusion Criteria:Any prior systemic MDM2-p53 inhibitor treatment Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to first dose.
Prior loco-regional treatment with intralesional therapy (e.g. talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 months prior to start of study treatment.
Received hormonal and biologic (<1 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days prior to first dose.
Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Or has neurologic instability per clinical evaluation due to tumor involvement of the CNS.
Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid: i.e.: topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, pIL-12) plus Electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment (PISCES)
The purpose of this voluntary research study is to find out what effects, good and/or bad, the combination of a type of gene therapy treatment called plasmid electroporation and pembrolizumab has on your cancer.
18 year(s) or older
Inclusion Criteria:Pathologically documented unresectable melanoma, American Joint Committee on Cancer (AJCC) version 8, Stage III or IV
Subjects must be refractory to anti-PD-1 monoclonal antibodies (pembrolizumab or nivolumab either as monotherapy or in combination with other approved checkpoint inhibitors or targeted therapies according to their approved label
Resolution/improvement of anti-PD1 mAb-related AEs (including immune related AEs; irAEs) back to Grade 0-1
BRAF V600 mutation-positive melanoma could have received standard of care targeted therapy for advanced or metastatic disease
Has a performance status of 0 or 1 on the ECOG Performance Scale
Exclusion Criteria:Subject has disease that is suitable for local therapy administered with curative intent
Clinically active CNS metastases
Subject with a diagnosis of uveal melanoma
Subject who had an allogenic tissue/solid organ transplant
Subjects with electronic pacemakers or defibrillators
A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma
This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.
18 year(s) or older
Inclusion Criteria:Age >=18 years.
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1
Exclusion Criteria:Participants who have received previous immunotherapy for any cancer (excluding melanoma) including PD-1/PD-L1 inhibitors but not interferons and CTLA-4 inhibitors.
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
Site for EA6192: A Phase II Study of Biomarker Driven Early Discontinuation of anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop) (PSCI# 20-097)
The purpose of this study is to compare the safety and effects of stopping the standard treatment with nivolumab or pembrolizumab early with the safety and effects of not stopping the standard treatment early on people’s risk of having advanced melanoma cancer spread more. In this study, you will continue on your standard of care treatment for one more year or you will discontinue your standard of care treatment. Whether you continue or stop treatment is dependent on the results of a PET/CT scan and, if needed, a biopsy. PET/CT scan can be useful for monitoring your type of cancer. There will be about 150 people taking part in this study.
18 year(s) or older
Inclusion Criteria:Patient must be ≥ 18 years of age.
Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by AJCC 8th edition
Patient must have an ECOG performance status of 0-2
Patient must have completed an FDG-PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy
For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable
Exclusion Criteria:Patient must not have brain metastases
Women must not be pregnant or breast-feeding
Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens
Site for A Phase III, Randomized, Open-label Study of Adjuvant Immunotherapy with Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Participants at High Risk for Recurrence (PIVOT-12)
This study is to compare the efficacy, as measured by recurrence-free survival (RFS) by a blinded independent central review (BICR) of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIa, Stage IIIb/c/d, or Stage IV no evidence of disease (NED) cutaneous melanoma who are at high risk for recurrence.
18 year(s) or older
Inclusion Criteria:Prior treated central nervous system (CNS) metastases must have magnetic resonance imaging (MRI) evidence of no recurrence for at least 4 weeks after treatment
Male or female patients age 12 years or older at the time of signing the informed consent form (ICF) (age 18 years or older where local regulations or institutional policies do not allow for patients < 18 years of age to participate).
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed Stage IIIA (LN metastasis > 1 mm [i.e., at least one LN metastasis measuring > 1 mm at greatest diameter]), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC
Tumor tissue from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis
Exclusion Criteria:Use of an investigational agent or an investigational device within 28 days before randomization
History of ocular/uveal melanoma or mucosal melanoma
Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
Prior therapy for melanoma
History of leptomeningeal disease