Advanced Solid TumorsPhase 1/2NCT02799095

A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

A Phase 1/2 study testing ALKS 4230 and ALKS 4230 + pembrolizumab in people with Advanced Solid Tumors, run by Mural Oncology, Inc at 31 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To better understand the safety and tolerability of ALKS 4230 in humans Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: ALKS 4230 and ALKS 4230 + pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 243 participants
Where: 31 sitesin 7 countries
Study dates: 14 Sep 2016to 2 Aug 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

For Part A, the subject has histological or cytological evidence of a solid tumor; for Part B, the subject has a diagnosis of melanoma or renal cell carcinoma
All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
Subjects enrolled in Part B or Part C must have at least 1 lesion that may qualify as a target lesion
Subject can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months
Subject must have adequate hematologic reserve
Subjects must have adequate liver function

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Subjects must have adequate kidney function
Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
Subjects who have received investigational agents must wait at least 4 weeks
Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered. A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as >45 years of age and without a menstrual period for 12 consecutive months
Meets contraceptive requirements defined in the protocol
Additional criteria may apply

Who cannot join

Subject is currently pregnant or breastfeeding, or is planning to become pregnant during the study
Subjects with an active infection or with a fever >/= 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1
Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable
Subjects have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males)
Subjects with known hypersensitivity to any components of ALKS 4230
Subjects with known hypersensitivity to any components of pembrolizumab (for patients in combination arm only)

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Subjects who require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy
Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study
The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
Subjects with dyspnea at rest of requiring oxygen therapy
Subjects active autoimmune disease requiring systemic treatment within the past 30 days
Subjects who received radiotherapy within the last 4 weeks before start of study treatment administration with the exception of limited field palliative radiotherapy
Subjects who have received systemic immunomodulatory agents within 28 days prior to C1D1.
Subjects who have received administration of a live, attenuated vaccine within 4 weeks of Cycle 1, Day1.
Prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant recipients
Subjects who have received prior IL-2 based or IL-15 based cytokine therapy
Additional criteria may apply

Trial locations and contacts

31 sites in 7 countries.

Country

City, postcode or hospital

31 sites in 7 countries

United States12 sites

Mural Oncology Investigational Site
Boston, Massachusetts, 02215
Mural Oncology Investigational Site
Buffalo, New York, 14203
Mural Oncology Investigational Site
Cleveland, Ohio, 44106
Mural Oncology Investigational Site
Dallas, Texas, 75230
Mural Oncology Investigational Site
Denver, Colorado, 80045
Mural Oncology Investigational Site
Detroit, Michigan, 47201
Mural Oncology Investigational Site
Fairfax, Virginia, 22031
Mural Oncology Investigational Site
Lexington, Kentucky, 40536
Mural Oncology Investigational Site
New York, New York, 10016
Mural Oncology Investigational Site
Port Saint Lucie, Florida, 34952
Mural Oncology Investigational Site
Spokane, Washington, 99208
Mural Oncology Investigational Site
Tampa, Florida, 33610

Other trials in United States

Spain6 sites

Mural Oncology Investigational Site
Barcelona, 8036
Mural Oncology Investigational Site
Madrid, 28033
Mural Oncology Investigational Site
Madrid, 28040
Mural Oncology Investigational Site
Madrid, 28041
Mural Oncology Investigational Site
Madrid, 28050
Mural Oncology Investigational Site
Valencia, 46010

Other trials in Spain

Canada5 sites

Mural Oncology Investigational Site
Edmonton, Alberta
Mural Oncology Investigational Site
Hamilton, Ontario
Mural Oncology Investigational Site
Montreal, Quebec
Mural Oncology Investigational Site
Québec, Quebec, G1R 2J6
Alkermes Investigational Site
Toronto, Ontario

Other trials in Canada

South Korea3 sites

Mural Oncology Investigational Site
Daejeon, 35015
Mural Oncology Investigational Site
Seoul, 02841
Mural Oncology Investigational Site
Seoul, 03722

Other trials in South Korea

Australia2 sites

Mural Oncology Investgational Site
Albury, New South Wales, 2640
Mural Oncology Investigational Site
Waratah, New South Wales, 2298

Other trials in Australia

Belgium2 sites

Mural Oncology Investigational Site
Brussels, MO, 1200
Mural Oncology Investigational Site
Kortrijk, West-Vlaanderen, 8500

Other trials in Belgium

Poland1 site

Mural Oncology Investigational Site
Skorzewo, Poznan, 60-185

Other trials in Poland

About this study

Official title: A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1

To better understand the safety and tolerability of ALKS 4230 in humans

Read the detailed description

To investigate the safety and tolerability of ALKS 4230, determine the recommended Phase 2 dose (RP2D) and assess anti-tumor activity in Monotherapy and ALKS 4230 in Combination with pembrolizumab.

Conditions: Advanced Solid Tumors
Being tested: ALKS 4230, ALKS 4230 + pembrolizumab
Keywords: Immunotherapy, IL-2, Interleukin-2, Solid tumors, Melanoma, Renal cell carcinoma, Non-small-cell lung cancer, Squamous cell carcinoma of the head and neck, in combination with pembrolizumab
Medical subject headings: Melanoma, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

ALKS 4230Drug
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
ALKS 4230 + pembrolizumabDrug
IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle

Study groups in NCT02799095
Study group	Role	What they receive
ALKS 4230	Experimental	Not described Receives: Drug: ALKS 4230
ALKS 4230 + pembrolizumab	Experimental	Not described Receives: Drug: ALKS 4230 + pembrolizumab

What is being measured

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

Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE)
DLT was defined by any of following events possibly, probably, or definitely related to ALKS 4230: Grade 4 neutrophil count decreased (neutropenia); Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; Thrombocytopenia; Any Grade 3 cardiac or central nervous system toxicity; Liver transaminase elevation higher than 8*upper limit of normal (ULN) or total bilirubin higher than 6*ULN; Grade 4 hypoalbuminemia; Fever more than (>) 40 degree Celsius (°C) sustained for >24 hours; Hypotension required the use of pressors or prolonged hospitalization (>48 hours) for hypotension requiring medical intervention; Grade 3 or higher electrolyte abnormalities; Increase in amylase or lipase; Grade 3 or higher nausea, vomiting, or diarrhea; Any other Grade 4 nonhematologic toxicity or any other Grade 3 non-hematologic toxicity; Any other toxicity or adverse event (AE) not defined above that resulted in participant removal from the study or discontinuation of dosing by the Investigator.
Measured: Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days)
Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product.
Measured: From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)
Parts A, B, and C: Number of Participants With TEAEs by Severity Grading
TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. Severity was graded according to the National Cancer Institute (NCI) CTCAE (version 4.03) where, Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. As planned, Grades 1 and 2 were combined for reporting.
Measured: From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)
Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
ORR rate was defined as the percentage of participants with objective evidence of CR or PR based on RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose of study drug up to 40.3 months for Part B and up to 50.5 months for Part C

Secondary outcomes (16)

Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa
Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.
Measured: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa
Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.
Measured: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa
Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.
Measured: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa
Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.
Measured: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA)
Overall proportion was calculated as: Number of participants (overall positive)/total number of participants in the cohort. Overall positive: Participants with at least 1 treatment-emergent ADA positive sample at any time during the treatment period.
Measured: From first dose of study drug up to 9 months (for Part A); up to 40.3 months (for Part B); up to 50.5 months (for Part C)
Parts A, B, and C: Immune ORR (iORR) Based on Immune RECIST (iRECIST)
iORR was defined as the percentage of participants with objective evidence of immune CR (iCR) or immune PR (iPR) based on iRECIST guidelines.
Measured: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1
Disease control rate was defined as the percentage of participants with objective evidence of CR, PR, or SD based on RECIST v.1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Parts A, B, and C: Immune DCR (iDCR) Based on iRECIST v1.1
iDCR was defined as the percentage of participants with objective evidence of iCR, iPR (where iCR or iPR required confirmation), or immune stable disease (iSD) (where the iSD requires to occur at Cycle 4 or later).
Measured: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1
Duration of response was defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: From the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C)
Parts B, and C: Immune DOR (iDOR) Based on iRECIST
iDOR was defined as the time from the first documentation of response (iCR or iPR) to the first documentation of objective tumor progression (immune confirmed progressive disease [iCPD]) or death due to any cause based on iRECIST.
Measured: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Part B and Part C Cohorts C5, C6, C7: Durable Response Rate (DRR) Based on RECIST v.1.1
DRR was defined as the percentage of participants with an objective response (complete or partial response per RECIST 1.1) lasting continuously for 6 months and starting any time within 12 months of initiating the study drug.
Measured: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Part B and Part C Cohorts C5, C6, C7: Immune DRR (iDRR) Based on iRECIST
iDRR was defined as the percentage of participants with an objective response (complete or partial response per iRECIST) lasting continuously for 6 months and starting any time within 12 months of initiating the study drug.
Measured: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1
Progression-free survival was defined as the time from the first dose of nemvaleukin to the first documentation of objective tumor progression or death due to any cause. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: From first dose of study drug up to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C)
Part B and Part C Cohorts C5, C6, C7: Immune PFS (iPFS)
iPFS was defined as the time from the first dose of study medication to the first documentation of objective tumor progression based on iRECIST (immune confirmed progressive disease [iCPD]) or death due to any cause.
Measured: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells
Measured: Cycle 1 Day 1 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C)
Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)
Measured: Cycle 1 Days 1 and 5; Cycle 2 Days 1 and 5 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts)

Timeline

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

14 Sep 20162 Aug 2023

First posted14 Jun 2016 (estimated)
Study start14 Sep 2016
Primary completion27 Mar 2023
Study completion2 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Parallel groups
Masking: None (open label)
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02799095
Sponsor's protocol ID: ALK4230-A101
Status last verified: May 2025
First submitted: 1 Jun 2016
Last updated: 21 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: At this time, IPD sharing has not been defined and/or decided if it will be shared.

Publications

Calvo E, Boni V, Dumas O, Shin SJ, Rosen SD, Chaudhry A, Debruyne PR, He X, Vaishampayan UN, McDermott DF. Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial. J Immunother Cancer. 2025 Aug 4;13(8):e010777. doi: 10.1136/jitc-2024-010777.
PubMed 40759440
Vaishampayan UN, Muzaffar J, Winer I, Rosen SD, Hoimes CJ, Chauhan A, Spreafico A, Lewis KD, Bruno DS, Dumas O, McDermott DF, Strauss JF, Chu QS, Gilbert L, Chaudhry A, Calvo E, Dalal R, Boni V, Ernstoff MS, Velcheti V. Nemvaleukin alfa, a modified interleukin-2 cytokine, as monotherapy and with pembrolizumab in patients with advanced solid tumors (ARTISTRY-1). J Immunother Cancer. 2024 Nov 20;12(11):e010143. doi: 10.1136/jitc-2024-010143.
PubMed 39567211

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1
ClinicalTrials.gov ID: NCT02799095
Acronym / sponsor ID: ALK4230-A101
Conditions: Advanced Solid Tumors
Keywords: Immunotherapy, IL-2, Interleukin-2, Solid tumors, Melanoma, Renal cell carcinoma, Non-small-cell lung cancer, Squamous cell carcinoma of the head and neck
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: Mural Oncology, IncIndustry (pharma, biotech, devices)
Study start: 14 Sep 2016 (actual)
Primary completion: 27 Mar 2023 (actual)
Study completion: 2 Aug 2023 (actual)
First posted: 14 Jun 2016 (estimated)
Results: Posted 21 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To better understand the safety and tolerability of ALKS 4230 in humans

Detailed description

To investigate the safety and tolerability of ALKS 4230, determine the recommended Phase 2 dose (RP2D) and assess anti-tumor activity in Monotherapy and ALKS 4230 in Combination with pembrolizumab.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ALKS 4230	Experimental	Drug: ALKS 4230
ALKS 4230 + pembrolizumab	Experimental	Drug: ALKS 4230 + pembrolizumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

For Part A, the subject has histological or cytological evidence of a solid tumor; for Part B, the subject has a diagnosis of melanoma or renal cell carcinoma
All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
Subjects enrolled in Part B or Part C must have at least 1 lesion that may qualify as a target lesion
Subject can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months
Subject must have adequate hematologic reserve

Key exclusion criteria (18 listed)

Subject is currently pregnant or breastfeeding, or is planning to become pregnant during the study
Subjects with an active infection or with a fever >/= 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1
Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable
Subjects have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males)
Subjects with known hypersensitivity to any components of ALKS 4230

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALKS 4230Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period	Drug	ALKS 4230
ALKS 4230 + pembrolizumabIV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle	Drug	ALKS 4230 + pembrolizumab

Primary outcome

Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days)
DLT was defined by any of following events possibly, probably, or definitely related to ALKS 4230: Grade 4 neutrophil count decreased (neutropenia); Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; Thrombocytopenia; Any Grade 3 cardiac or central nervous system toxicity; Liver transaminase elevation higher than 8*upper limit of normal (ULN) or total bilirubin higher than 6*ULN; Grade 4 hypoalbuminemia; Fever more than (>) 40 degree Celsius (°C) sustained for >24 hours; Hypotension required the use of pressors or prolonged hospitalization (>48 hours) for hypotension requiring medical intervention; Grade 3 or higher electrolyte abnormalities; Increase in amylase or lipase; Grade 3 or higher nausea, vomiting, or diarrhea; Any other Grade 4 nonhematologic toxicity or any other Grade 3 non-hematologic toxicity; Any other toxicity or adverse event (AE) not defined above that resulted in participant removal from the study or discontinuation of dosing by the Investigator.
Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)
TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product.
Parts A, B, and C: Number of Participants With TEAEs by Severity Grading
Time frame: From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)
TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. Severity was graded according to the National Cancer Institute (NCI) CTCAE (version 4.03) where, Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. As planned, Grades 1 and 2 were combined for reporting.
Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Time frame: From first dose of study drug up to 40.3 months for Part B and up to 50.5 months for Part C
ORR rate was defined as the percentage of participants with objective evidence of CR or PR based on RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

16 secondary outcomes

Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa
Time frame: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa
Time frame: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa
Time frame: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa
Time frame: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA)
Time frame: From first dose of study drug up to 9 months (for Part A); up to 40.3 months (for Part B); up to 50.5 months (for Part C)
Parts A, B, and C: Immune ORR (iORR) Based on Immune RECIST (iRECIST)
Time frame: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1
Time frame: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Parts A, B, and C: Immune DCR (iDCR) Based on iRECIST v1.1
Time frame: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1
Time frame: From the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C)
Parts B, and C: Immune DOR (iDOR) Based on iRECIST
Time frame: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Part B and Part C Cohorts C5, C6, C7: Durable Response Rate (DRR) Based on RECIST v.1.1
Time frame: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Part B and Part C Cohorts C5, C6, C7: Immune DRR (iDRR) Based on iRECIST
Time frame: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1
Time frame: From first dose of study drug up to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C)
Part B and Part C Cohorts C5, C6, C7: Immune PFS (iPFS)
Time frame: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells
Time frame: Cycle 1 Day 1 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C)
Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)
Time frame: Cycle 1 Days 1 and 5; Cycle 2 Days 1 and 5 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts)

Results and safety

Results posted to the registry on 21 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	5	0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	4	0
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg	7	0
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg	8	0
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg	12	0
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg	3	0
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg	7	0
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	0	0
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	0	0
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg	0	0
Part C, Combination Therapy, Cohort 1 + Safety Run-in: Nemvaleukin Alfa 3mcg/kg +Pembrolizumab 200mg	0	0
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	0	0
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	0	0
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	0	0
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	0	0
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	0	0
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	0	0

Primary outcome: Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE)

Time frame: Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days). Count of participants. Unit: Participants

Measure	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg n = 5	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg n = 4	Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg n = 7	Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg n = 8	Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg n = 12	Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg n = 3	Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg n = 7
Value	0	0	0	2	3	0	1

Population analysed: Safety population included all participants who received at least 1 dose of nemvaleukin alfa or pembrolizumab.

Primary outcome: Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C). Count of participants. Unit: Participants

Measure	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg n = 5	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg n = 4	Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg n = 7	Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg n = 8	Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg n = 12	Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg n = 3	Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg n = 7	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg n = 47	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg n = 27	Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg n = 3	Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg n = 42	Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 26	Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 26	Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 43	Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 3	Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 21	Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 2
Value	5	4	7	8	12	3	7	46	27	3

Primary outcome: Parts A, B, and C: Number of Participants With TEAEs by Severity Grading

Measure	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg n = 5	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg n = 4	Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg n = 7	Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg n = 8	Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg n = 12	Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg n = 3	Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg n = 7	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg n = 47	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg n = 27	Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg n = 3	Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg +Pembrolizumab 200mg n = 42	Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 26	Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 26	Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 43	Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 3	Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 21	Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 2
Participants With Grade 1 and 2 TEAEs	2	3	4	2	3	1	1	6	5	3	16

Primary outcome: Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

Time frame: From first dose of study drug up to 40.3 months for Part B and up to 50.5 months for Part C. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg n = 46	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg n = 22	Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg n = 3	Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg +Pembrolizumab 200mg n = 36	Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 22	Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 21	Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n = 39	Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 3	Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 18	Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg n = 2
Value	8.7 (2.4 to 20.8)	13.6 (2.9 to 34.9)	0.0 (0.0 to 70.8)	13.9 (4.7 to 29.5)	0.0 (0.0 to 15.4)	28.6 (11.3 to 52.2)	7.7 (1.6 to 20.9)	66.7 (9.4 to 99.2)	11.1 (1.4 to 34.7)	50.0 (1.3 to 98.7)

Population analysed: The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	2 of 5 (40%)	5 of 5 (100%)	0 of 5
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg	2 of 7 (28.6%)	7 of 7 (100%)	0 of 7
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg	3 of 8 (37.5%)	8 of 8 (100%)	0 of 8
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg	5 of 12 (41.7%)	12 of 12 (100%)	1 of 12
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg	5 of 7 (71.4%)	7 of 7 (100%)	3 of 7
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	11 of 47 (23.4%)	46 of 47 (97.9%)	7 of 47
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	12 of 27 (44.4%)	27 of 27 (100%)	7 of 27
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg +Pembrolizumab 200mg	19 of 42 (45.2%)	42 of 42 (100%)	7 of 42
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	10 of 26 (38.5%)	26 of 26 (100%)	7 of 26
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	11 of 26 (42.3%)	25 of 26 (96.2%)	8 of 26
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	14 of 43 (32.6%)	38 of 43 (88.4%)	8 of 43
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40759440Calvo E, Boni V, Dumas O, Shin SJ, Rosen SD, Chaudhry A, Debruyne PR, He X, Vaishampayan UN, McDermott DF. Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial. J Immunother Cancer. 2025 Aug 4;13(8):e010777. doi: 10.1136/jitc-2024-010777.
Derived from this study: PubMed 39567211Vaishampayan UN, Muzaffar J, Winer I, Rosen SD, Hoimes CJ, Chauhan A, Spreafico A, Lewis KD, Bruno DS, Dumas O, McDermott DF, Strauss JF, Chu QS, Gilbert L, Chaudhry A, Calvo E, Dalal R, Boni V, Ernstoff MS, Velcheti V. Nemvaleukin alfa, a modified interleukin-2 cytokine, as monotherapy and with pembrolizumab in patients with advanced solid tumors (ARTISTRY-1). J Immunother Cancer. 2024 Nov 20;12(11):e010143. doi: 10.1136/jitc-2024-010143.
Individual participant dataSharing planned: No. At this time, IPD sharing has not been defined and/or decided if it will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Mural Oncology

31 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ALKS 4230 and ALKS 4230 + pembrolizumab in people with Advanced Solid Tumors, run by Mural Oncology, Inc at 31 sites in 7 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 12 inclusion and 18 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: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Spain, Canada, South Korea, Australia and 2 more countries. 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?

Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) (time frame: Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days)). The study lists 4 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 NCT02799095, which also lists 2 linked publications.

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 21 May 2025.