Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age >= 18 years
Disease characteristics:
Newly diagnosed, recurrent, or previously treated in-transit metastatic melanoma (ITM) confined to a single limb with or without regional lymph node involvement
For patients with ITM, one of the following must be true:
Newly diagnosed, recurrent or previously treated metastatic melanoma of the lymph nodes in lymphatic beds accessible to limb-lymphatic infusion (Example: lower limb lymphatic accessible femoral, inguinal pelvic and/or retroperitoneal lymph node metastases; upper limb: axillary, infraclavicular and/or subclavian lymph node metastases)
For patients with lymph node metastases only (non ITM) the following must be true:
Hemoglobin >= 8.0 g/dL (obtained =< 15 days prior to registration)
Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 15 days prior to registration)
Platelet count >= 75,000/mm^3 (obtained =< 15 days prior to registration)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 15 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3.0 x ULN (obtained =< 15 days prior to registration)
Serum creatinine =< 2.0 × ULN (obtained =< 15 days prior to registration)
Calculated creatinine clearance >= 40 ml/min using the Cockcroft-Gault formula (obtained =< 15 days prior to registration)
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT, aPTT) PT/INR/aPTT =< 1.5 × ULN or if patient is receiving anticoagulant therapy INR or aPTT is within target range of therapy (Within 15 days prior to registration)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only.
Persons able to become pregnant or able to father a child must be willing to use an adequate method of contraception while on treatment and for 180 days (6 months) after last treatment dose on this study
Provide written informed consent
Rochester only: Willingness to provide mandatory blood specimens for correlative research
Willingness to provide mandatory tissue specimens for correlative research
Willing to return to enrolling institution for 3-month follow-up (during the Active Monitoring Phase of the study)
Exclusion criteria
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
Metastatic melanoma beyond in-transit metastases (ITM) and regional lymph nodes (LNs) that cannot be accessed by intralymphatic infusion by DoseConnect (example: visceral or active central nervous system [CNS] metastatic disease)
ITM involving the hands and feet (not accessible to DoseConnect infusion)
ITM NOT involving a limb (i.e., head, neck, or trunk)
Prior radiation of ITM that are being evaluated as measurable lesions
Any of the following prior therapies:
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
Active autoimmune disease requiring systemic treatment < 2 years prior to registration, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents with use of disease modifying agents, corticosteroids, or immunosuppressive drugs
NOTE: Exceptions are allowed for the following conditions:
Vitiligo
Resolved childhood asthma/atopy
Intermittent use of bronchodilators or inhaled steroids
Daily steroids at dose of =< 10mg of prednisone (or equivalent)
Local steroid injections
Stable hypothyroidism on replacement therapy
Stable diabetes mellitus on therapy (with or without insulin)
Sjogren's syndrome
Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) which is not considered a form of systemic treatment and is allowed
Ongoing or active infection requiring systemic therapy
Interstitial lung disease
Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn's disease or others)
Known history of hepatitis B (i.e., known positive hepatitis B virus [HBV] surface antigen [HBsAg] reactive)
Known active hepatitis C (i.e., positive for hepatitis C virus [HCV] ribonucleic acid [RNA] detected by polymerase chain reaction [PCR])
Known active tuberculosis (TB)
Symptomatic congestive heart failure
Unstable angina pectoris
Unstable cardiac arrhythmia or
Psychiatric illness/social situations that would limit compliance with study requirements (e.g., known substance abuse)
Chemotherapy
Immunotherapy
Targeted therapies (e.g., dabrafenib)
Other investigational agents
Radiation therapy
Minor surgical or interventional procedure (NOTE: Biopsy of same limb for diagnosis is allowed)
Major surgical procedure
Primary purpose
Allocation
Interventional model
Masking
3 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal