Symptoms and General Pathology

All Conditions

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Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

The research study procedures include screening for eligibility, study treatment including evaluations, surveys, optional biopsies, and follow up visits

Olaparib- Each study treatment cycle lasts 28 days . This will continue for as long as the study treatment is providing clinical benefit

Oral, twice a day, dosage per protocol, per 28 day cycle

Tamara Sussman, MD

The purpose of this study is to evaluate how effective Olaparib is when given as a treatment for primary or recurrent, unresectable or metastatic melanoma. This research study involves targeted therapy.

-The name of the study drug involved in this study is: Olaparib (also known as Lynparza)

A phase II, single arm, open label pilot trial in a sample size of 15 primary or recurrent, unresectable or metastatic melanoma patients that have progressed on prior checkpoint inhibitor therapy with germline or somatic mutations in BRCA1/2.

The research study procedures include screening for eligibility, study treatment including evaluations, surveys, optional biopsies, and follow up visits. This research study involves targeted therapy.

* The name of the study drug involved in this study is:
* Olaparib (also known as Lynparza)

It is expected that about 15 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

This research study is a Pilot Study, which is the first time investigators are examining this drug for treatment of melanoma.

The U.S. Food and Drug Administration (FDA) has not approved Olaparib for this specific disease, but it has been approved for other uses.

AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and the study drug, Olaparib.

Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2

Pilot Trial of Olaparib in Patients With Unresectable or Metastatic Melanoma With Mutations in BRCA1/2 Genes

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Best overall response (CR+PR) assessed by RECIST v1.1

NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0,

(Complete Response+ Partial Response + Stable Disease) by RECIST v1.1

AstraZeneca

Dana-Farber Cancer Institute

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunologic Factors

Patients receive STI-3031 intra-lymphatically via the DoseConnect device over 1-8 hours QW on days 1, 8, 15, 22, 29, and 36 of cycle 1, and Q2W on days 1, 15, and 29 of cycle 2. Treatment repeats every 42 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR at the end of cycle 2 receive 1-2 additional cycles in the absence of disease progression or unacceptable toxicity. Patients with PR or SD at the end of cycle 2 continue treatment for a total of 9 cycles in the absence of disease progression or unacceptable toxicity.

Given intra-lymphatically via DoseConnect device

Anti-PD-L1 Monoclonal Antibody IMC-001

Punch Biopsy

Anastasios Dimou, M.D.

This phase Ib trial tests the safety, side effects, and best dose of STI-3031 given directly into the into the lymph nodes or the lymph vessels (intra-lymphatic) using the Sofusa DoseConnect device in treating patients with melanoma that has spread through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node (in-transit). Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE:

I. To determine the feasibility, safety, and maximum tolerated dose (MTD) of anti-PD-L1 monoclonal antibody IMC-001 (STI-3031) that can be administered through the DoseConnect device in patients with metastatic melanoma demonstrating in-transit and/or regional lymph node metastases.

SECONDARY OBJECTIVE:

I. To assess clinical benefit rates to STI-3031 administered via DoseConnect device in patients with melanoma in-transit and/or reginal lymph node metastases.

CORRELATIVE OBJECTIVES:

I. To assess lymphatic drainage of the affected extremity via intralymphatic indocyanine green (ICG) prior to first treatment cycle and prior to last treatment cycle.

II. To assess for changes in antitumor immunity as a result of therapy.

OUTLINE:

Patients receive STI-3031 intra-lymphatically via the DoseConnect device over 1-8 hours once weekly (QW) on days 1, 8, 15, 22, 29, and 36 of cycle 1, and once every 2 weeks (Q2W) on days 1, 15, and 29 of cycle 2. Treatment repeats every 42 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) at the end of cycle 2 receive 1-2 additional cycles in the absence of disease progression or unacceptable toxicity. Patients with partial response (PR) or stable disease (SD) at the end of cycle 2 continue treatment for a total of 9 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 2-4 weeks, 90 days and every 3 months for up to 2 years after study enrollment.

Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study

Phase 1 Study of the Administration of STI-3031 (Anti-PDL1) Intra-Lymphatically Using the Sofusa® DoseConnect™ DEVICE in Patients With In-Transit Melanoma (Sofusa-2)

Descriptive analysis will be performed to report these findings.

The ICG lymphography classification of the functional status of the lymphatic system first described by Yamamoto et al (Yamamoto 2011) will be utilized. Utilizing descriptive statistics, we will note any changes in the ICG flow patterns and if any improvement or deterioration appears associated with in-transit metastasis (ITM) response, stability, or progressive disease. This work will be exploratory and hypothesis generating.

MTD is the dose level where at most 1 of the 6 patients treated at that dose level develops a dose limiting event (DLE) during the first cycle of treatment and neither a Grade 3 or worse AE attributable to either drug or device or a Grade 2 or worse adverse event (AE) lasting \>= 1 week and attributable to device is reported after the first cycle of treatment.

The maximum grade of each type of adverse event will be recorded for each patient. For each adverse event reported by dose level, the percentage of patients developing any degree of that adverse event as well as the percentage of patients developing a severe degree (Grade 3 or higher) will be determined.

Defined as the number of patients who complete 3 cycles of treatment and whose objective tumor status by Response Evaluation Criteria in Solid Tumors (RECIST) is stable, partial response (PR) or complete response (CR) post discontinuation among all eligible patients enrolled.

If a patient dies without a recurrence documented, the patient will be censored at the date of their last disease evaluation unless there is documentation that the patient was progression-free within 3 months of death. PFS distribution will be estimated using the Kaplan-Meier method.

Defined as the proportion of patients whose tumor meets the criteria for PR or CR on two consecutive evaluations at least 12 weeks apart among all eligible patients who began treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2	NCT05482074	Recurrent Metas... Cutaneous Melan... Mucosal Melanom... Uveal Melanoma	Olaparib	18 Years -	Dana-Farber Cancer Institute
Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study	NCT05393713	Clinical Stage ... Melanoma Metastatic Mela... Recurrent Metas...	Anti-PD-L1 Mono... Punch Biopsy	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for recurrent metastatic melanoma