Clinical Trials in Spain / NCT04592653
Active, not recruiting
Phase 1/2
Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3)
NCT04592653 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Advanced Solid Tumor
Investigational drug(s) / intervention(s)
Nemvaleukin alfaPembrolizumab →
Nemvaleukin alfa: IV infusion over 30 minutes
Pembrolizumab: IV infusion over 30 minutes
Study summary
The study will be conducted in 2 cohorts. A single-center design for the tumor microenvironment (TME) cohort (Cohort 1), and a multicenter design for the less frequent intravenous (IV) dosing cohort (Cohort 2).
Eligibility
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed diagnosis of an advanced solid tumor type of cutaneous melanoma, RCC, TNBC, MSS colorectal cancer, MSI-H solid tumors (NOS), or ovarian cancer with at least 1 accessible lesion for biopsy (Cohort 1 TME)
* Patients must have histologically or cytologically confirmed epithelial tumor of the fallopian tube, peritoneum, or ovaries, cervical cancer, endometrial cancer, non-small cell lung adenocarcinoma, small cell lung cancer, gastric and gastroesophageal junction adenocarcinoma, esophageal cancer (squamous and adeno cell type), pancreatic cancer, biliary tract tumor (including intra- and extrahepatic cholangiocarcinoma, gall bladder, ampullary type), cutaneous melanoma, mucosal melanoma, head and neck squamous cell carcinoma, or metastatic or advanced breast cancer after treatment failure or intolerance of 1 to 3 established indication specific therapies (Cohort 2)
* Patient must have received 1 to 3 prior FDA-approved targeted therapies, failure of adjuvant and neoadjuvant therapy is considered 1 line of treatment
* All patients' baseline biopsies must be taken no more than 3 months before Screening and at least 4 weeks after completion of last antineoplastic therapy
* Patients must have at least 1 lesion that qualifies as a target lesion
* Patients must have adequate hematologic reserve
* Patients must have adequate hepatic and renal function
* For Cohort 1 (TME) and Part A of Cohort 2 (less frequent IV dosing), treatment with prior immunotherapy is permitted unless the patient has previously experienced grade ≥3 autoimmune toxicity or drug-related toxicity requiring discontinuation. Patients in Part B of Cohort 2 (less frequent IV dosing) who received prior anti-PD-(L)1 for at least 3 months may enroll if they had a response of stable disease or better
* For Cohort 1 (TME), patients who have received prior anti-PD-1 directed therapy must wait at least 4 weeks from last dose of such therapy before the Screening biopsy is collected
* Women of childbearing potential (WOCBP) must have a negative pregnancy test
* Additional criteria may apply
Exclusion Criteria:
* Patients with active or symptomatic central nervous system metastases
* Patients who require pharmacologic doses of systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent)
* Patients known to be positive for HIV and/or history of hepatitis B, or C infections or is known to be positive for hepatitis B antigen (HBsAg)/hepatitis B virus (HBV) DNA or hepatitis C antibody (Hep C Ab) or RNA.
* Patients with a known additional malignancy within 2 years of the start of Screening
* Patients who have received radiotherapy within the last 4 weeks before start of study treatment
* Patients who have received systemic immunomodulatory agents within 4 weeks or 5 half lives, whichever is shorter, before Cycle 1 Day 1,
* Patients who have received prior IL-2-based or IL-15-based soluble protein therapy at any time in the past are excluded
* Additional criteria may apply
Primary outcome measure(s)
- Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) — From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy
Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies - Changes in ratios (including T/Treg, CD8+/Treg, CD56+/Treg) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies — From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy
- Incidence of dose-limiting toxicity (DLT) — From the first dose through end of dose-limiting toxicity observation period (up to 24 months)
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| START Midwest | Grand Rapids | Michigan | |
| MD Anderson Cancer Center | Houston | Texas | |
| START Mountain | West Valley City | Utah | |
| NEXT Virginia | Fairfax | Virginia | |
| Hospital Clinico San Carlos | Madrid | Spain | |
| CIOCC HM Sanchinarro | Madrid | Spain |
On this site
📄 Keytruda (pembrolizumab) drug profile →Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04592653 on ClinicalTrials.gov ↗ ← All trials in Spain