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The purpose of this study is to test the effects of anti-PI-1 inhibitor (TSR-042) or anti-PD-1/anti-TIM-3 combination (TSR-042 / TSR-022) in patients with operable melanoma.
This is a randomized phase II neoadjuvant study comparing neoadjuvant therapy with PD-1 inhibitor Dostarlimab (TSR-042) to the PD-1/TIM-3 inhibitor combination Dostarlimab (TSR-042)/TSR-022 in patients with resectable regionally advanced or oligometastatic melanoma.
Patients with stage III B/C/D or oligometastatic stage IV A melanoma with lymph node (LN) and/or in-transit and/or oligometastatic disease who have yet to undergo definitive surgery are eligible to enroll.
Suitable patients will be identified pre-operatively. Patients will undergo screening evaluation consisting of systemic/CNS staging scans, tumor biopsy, blood studies to confirm suitability. Subjects will receive neoadjuvant therapy (Dostarlimab (TSR-042) or Dostarlimab (TSR-042)/TSR-022 combination for 6 weeks prior to planned surgery (pre-operative phase). Surgery will occur 1-4 weeks after completion of pre-operative therapy. After recovery from surgery subjects will receive Dostarlimab (TSR-042) (maintenance phase) for approximately 48 weeks; for a total of 54 weeks of study drug(s) administration in total.
Melanoma Stage III
Dostarlimab (TSR-042) (singly), Dostarlimab (TSR-042) and TSR-022 (combination)
UPMC Hillman Cancer Center
Not yet recruiting
University of Pittsburgh
Published on BioPortfolio: 2019-10-30T14:03:42-0400
This is a Phase 3, randomized, double-blind, multicenter study to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in ...
The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab is more effective than nivolumab or ipilimumab alone in treatmen...
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RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Phase II trial to study the effectiveness ...
Current literature supports mixed conclusions regarding the outcomes of metastatectomy in Stage IV melanoma. The objective of this national study was to determine the associations of non-primary site ...
Neoadjuvant PD-1 Blockade in Resectable Lung Cancer; Nivolumab and Ipilimumab in Advanced Melanoma; Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma; Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy; Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma; Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma; Niv
Patients diagnosed with metastatic melanoma have varied clinical courses, even in patients with similar disease characteristics. We examine the impact of initial stage of melanoma diagnosis, BRAF stat...
Combination ipilimumab and nivolumab is a highly active systemic therapy for metastatic melanoma but can cause significant toxicity. We explore the safety and efficacy of this treatment in routine cli...
When diagnosed at stage 0-I, melanoma has a 5-year survival rate of 92% to 100% in comparison with stage IV, which has a 5-year survival rate of 15% to 20%.
A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.
An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)
Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.
A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.
Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and malignant melanoma. Basal cell carcinoma Basal cell carcinoma, or BCC, is a cancer of the basal cells at the bottom of the epidermis. It’s very common ...