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Advanced Solid TumorPhase 1/2ARTISTRY-3NCT04592653

Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3)

A Phase 1/2 study testing Nemvaleukin alfa and Pembrolizumab in people with Advanced Solid Tumor, run by Mural Oncology, Inc at 6 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Nemvaleukin alfa and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
6 sitesin 2 countries
Study dates
30 Sep 2020to Dec 2024
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States4 sites

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • START Midwest

    Grand Rapids, Michigan, 49546

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • START Mountain

    West Valley City, Utah, 84119

Other trials in United States

Spain2 sites

  • Hospital Clinico San Carlos

    Madrid, 28040

  • CIOCC HM Sanchinarro

    Madrid, 28050

Other trials in Spain

About this study

Official title: Clinical and Immunologic Activity of Nemvaleukin Alfa With Less Frequent IV Dosing Schedule as Monotherapy and in Combination With Pembrolizumab and Impact on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3

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).

Being tested
Nemvaleukin alfa, Pembrolizumab
Keywords
Alkermes, IL-2, Interleukin-2, Oncology, Immuno-oncology, Cytokine, Pembrolizumab, Keytruda, PD-L1, Solid tumors, Immunotherapy, Nemvaleukin
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nemvaleukin alfaBiological

    Also called ALKS 4230

    IV infusion over 30 minutes

  • PembrolizumabBiological

    Also called Keytruda

    IV infusion over 30 minutes

Study groups in NCT04592653
Study groupRoleWhat they receive
Cohort 1: Tumor Microenvironment (TME) Nemvaleukin and PembrolizumabExperimentalNemvaleukin will be administered via Intravenous (IV) infusion given daily for 5 consecutive days followed by an off-treatment period. Starting on Cycle 3, Day 1 of each cycle, Pembrolizumab will be administered via IV infusion followed by IV infusion of nemvaleukin
Receives: Biological: Nemvaleukin alfa; Biological: Pembrolizumab
Cohort 2 Part A: Less Frequent IV Dosing NemvaleukinExperimentalNot described
Receives: Biological: Nemvaleukin alfa
Cohort 2 Part B: Less Frequent IV Dosing Nemvaleukin and PembrolizumabExperimentalThis arm will not open for enrollment.
Receives: Biological: Nemvaleukin alfa; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells)

    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

    Measured: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy

  2. 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

    Measured: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy

  3. Incidence of dose-limiting toxicity (DLT)

    Measured: From the first dose through end of dose-limiting toxicity observation period (up to 24 months)

Secondary outcomes (11)

  1. Proportion of subjects with objective evidence of Complete or Partial Response [(CR)/immune CR (iCR) or (PR) immune PR (iPR)](CR)/immune CR (iCR)

    Measured: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months

  2. Duration of response in subjects with Complete or Partial Response [(CR)/immune CR (iCR) or (PR) immune PR (iPR)]

    Measured: Time from the first documentation of complete response or partial response to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)

  3. Incidence of Adverse Events

    Measured: Time from first dose of study drug to the end of study (estimated up to 24 months)

  4. Incidence of drug-related Serious Adverse Events

    Measured: Time from first dose of study drug to the end of study (estimated up to 24 months)

  5. Incidence of drug-related Adverse Events leading to discontinuation

    Measured: Time from first dose of study drug to the end of study (estimated up to 24 months)

  6. Serum concentrations of ALKS 4230

    Concentration data will be summarized by dose level

    Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

  7. Serum will be assayed for the presence of anti-ALKS 4230 antibodies

    Results will be summarized by dose level

    Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

  8. Changes in absolute cell numbers (including total T cells, CD8+ T cells, NK cells and Treg cells)

    Changes in absolute cell numbers (including total T cells, CD8+ T cells, NK cells and Treg cells) between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab

    Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

  9. Changes in ratios (including T/Treg, CD8+/Treg, NK/Treg) between pretreatment and on treatment

    Changes in ratios (including T/Treg, CD8+/Treg, NK/Treg) between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab

    Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

  10. Serum concentrations of proinflammatory cytokines, including IFNγ, TNF-α, IL-1B, IL-6, IL-10, will be assessed using a multiplex method from initiation of therapy

    Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

  11. Changes in absolute numbers of circulating leukocytes

    Changes in absolute numbers of circulating leukocytes between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab

    Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start30 Sep 2020
  3. Primary completionJul 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04592653
Sponsor's protocol ID
ALKS 4230-003
Acronym
ARTISTRY-3
Status last verified
Jan 2024
First submitted
24 Aug 2020
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nemvaleukin alfa and Pembrolizumab in people with Advanced Solid Tumor, run by Mural Oncology, Inc at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) (time frame: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04592653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.

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