Advanced Solid TumorsPhase 1/2NCT03861793
A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)
A Phase 1/2 study testing ALKS 4230 and Pembrolizumab in people with Advanced Solid Tumors, run by Mural Oncology, Inc at 48 sites in 6 countries.
Trial summary
This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab. 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 Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 48 sitesin 6 countries
- Study dates
- 26 Feb 2019to 1 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types: gastric, ovarian, lung, head and neck.
- Subject must have at least one target lesion based on RECIST
- Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Subjects must have adequate liver function
- 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
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- Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study
- 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
- Subject will agree to follow contraceptive requirements defined in the protocol
- Additional criteria may apply
Who cannot join
- Subject is currently pregnant, planning to become pregnant, or breastfeeding
- Subjects with an active infection or with a fever ≥ 38.5°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 with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
- Subjects who require pharmacologic doses of systemic corticosteroids are excluded; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
- Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy
Show all 9Show fewer
- Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects 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
- Additional criteria may apply
Trial locations and contacts
48 sites in 6 countries.
48 sites in 6 countries
United States17 sites
Mural Oncology Investigational Site
Atlanta, Georgia, 30322
Mural Oncology Investigational Site
Bethesda, Maryland, 20817
Mural Oncology Investigational Site
Buffalo, New York, 14263
Mural Oncology Investigational Site
Charleston, South Carolina, 29425
Mural Oncology Investigational Site
Chicago, Illinois, 60612
Mural Oncology Investigational Site
Cincinnati, Ohio, 45229
Mural Oncology Investigational Site
Detroit, Michigan, 48201
Mural Oncology Investigational Site
Houston, Texas, 77030
Mural Oncology Investigational Site
Huntersville, North Carolina, 28078
Mural Oncology Investigational Site
Los Angeles, California, 90025
Mural Oncology Investigational Site
Los Angeles, California, 90211
Mural Oncology Investigational Site
Milwaukee, Wisconsin, 53226
Mural Oncology Investigational Site
Morristown, New Jersey, 07962
Mural Oncology Investigational Site
Philadelphia, Pennsylvania, 19111
Mural Oncology Investigational Site
Saint Paul, Minnesota, 55101
Mural Oncology Investigational Site
Salt Lake City, Utah, 84119
Mural Oncology Investigational Site
Washington D.C., District of Columbia, 20007
Spain9 sites
Mural Oncology Investigational Site
Badalona, 08916
Mural Oncology Investigational Site
Córdoba, 14004
Mural Oncology Investigational Site
Madrid, 28007
Mural Oncology Investigational Site
Madrid, 28040
Mural Oncology Investigational Site
Madrid, 28041
Mural Oncology Investigational Site
Madrid, 28050
Mural Oncology Investigational Site
Madrid, 28222
Mural Oncology Investigational Site
Málaga, 29010
Mural Oncology Investigational Site
Valencia, 46010
South Korea8 sites
National Cancer Center
Goyang, 10408
Inha University Hospital
Incheon, 22332
Seoul National University Bundang Hospital
Seongnam, 13620
Seoul National University Hospital
Seoul, 03080
Yonsei University Health System - Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 6351
The Catholic University of Korea St. Vincent's Hospital
Suwon, 16247
Canada6 sites
Mural Oncology Investigational Site
Edmonton, Alberta, T6G 1Z2
Mural Oncology Investigational Site
Hamilton, Ontario, L8V 5C2
Mural Oncology Investigational Sites
Montreal, Quebec, H2X 0C1
Mural Oncology Investigational Site
Montreal, Quebec, H3A 3J1
Mural Oncology Investigational Site
Montreal, Quebec, H3T 1E2
Mural Oncology Investigational Site
Québec, Quebec, G1R 2J6
Taiwan6 sites
Mural Oncology Investigational Site
Kaohsiung City, 83301
Mural Oncology Investigational Site
Taichung, 40447
Mural Oncology Investigational Site
Tainan, 704
Mural Oncology Investigational Site
Taipei, 100
Mural Oncology Investigational Site
Taipei, 11217
Mural Oncology Investigational Site
Taipei, 11259
Netherlands2 sites
Mural Oncology Investigational Site
Rotterdam, 3000 CA
Mural Oncology Investigational Site
Utrecht, 3508 GA
About this study
Official title: A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)
This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
Read the detailed description
This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- ALKS 4230, Pembrolizumab
- Keywords
- Alkermes, IL-2, Interleukin-2, Oncology, Immuno-oncology, Cytokine, ALKS 4230, Pembrolizumab, Keytruda, PD-L1, Solid tumors, Immunotherapy, nemvaleukin alfa, ovarian, Head and Neck, NSCLC, Non small cell lung cancer, lung cancer, Gastric, Gastric Cancer
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Stomach Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 4230Biological
SC injection administered in the back of the arm or the abdomen
PembrolizumabBiological
Also called Keytruda
Administered as an intravenous (IV) infusion over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| ALKS 4230 | Experimental | Administered via SC injection once every 7 days or once every 21 days at escalating doses Receives: Biological: ALKS 4230 |
| ALKS 4230 + pembrolizumab | Experimental | ALKS 4230 will be administered via SC injection once every 7 or 21 days at escalating doses or at the recommended phase 2 dose and schedule; pembrolizumab will be administered as an intravenous infusion given over 30 minutes; the dose level for pembrolizumab will be 200 mg per the approved label. In December 2020, an RP2D of 3 mg with an administration schedule of q7d was determined for SC ALKS 4230. Receives: Biological: ALKS 4230; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A
Includes AEs that are both serious and drug-related
Measured: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Number of subjects experiencing AEs that are both serious and drug-related in Part B
Includes AEs that are both serious and drug-related
Measured: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Clinical Activity of combination treatment with ALKS 4230 and pembrolizumab in each Part B tumor type.
Overall Response rate (ORR) will be based on investigator review of radiographic and photographic images
Measured: From time of therapy until the date of first documented tumor progression, assessed up to 24 months
Secondary outcomes (10)
Proportion of subjects with objective evidence of Complete Response (CR)/immune CR (iCR)
Overall response rate (ORR) will be based on investigator review of radiographic or photographic images
Measured: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Proportion of subjects with objective evidence of Partial Response (PR)/immune PR (iPR)
ORR will be based on investigator review of radiographic or photographic images
Measured: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Duration of response in subjects with CR/iCR
CR/iCR duration
Measured: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Duration of response in subjects with PR/iPR
PR/iPR duration
Measured: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Non-progression for Part B
Time from first dose of SC ALKS 4230 to the time of progression or death
Measured: Assessed up to 24 months
Overall survival for Part B
Time from first dose of SC ALKS 4230 to the time of death
Measured: Assessed up to 24 months
Serum concentrations of ALKS 4230 will be determined at various time points
Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level
Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
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 21 days), assessed up to 24 months
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Results will be summarized by dose level
Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points
Results will be summarized by dose level
Measured: From time of initiation of therapy until the last treatment cycle (each cycle is 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.
- First posted4 Mar 2019
- Study start26 Feb 2019
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mural Oncology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mural Oncology Medical Director, Study director, Mural Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861793
- Sponsor's protocol ID
- ALKS 4230-001
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2019
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, IPD sharing has not been defined and/or decided if it will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)
- ClinicalTrials.gov ID
- NCT03861793
- Acronym / sponsor ID
- ALKS 4230-001
- Conditions
- Advanced Solid Tumors
- Keywords
- Alkermes, IL-2, Interleukin-2, Oncology, Immuno-oncology, Cytokine, ALKS 4230, Pembrolizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Mural Oncology, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
Detailed description
This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.
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 | Biological: ALKS 4230Administered via SC injection once every 7 days or once every 21 days at escalating doses |
| ALKS 4230 + pembrolizumab | Experimental | Biological: ALKS 4230, Biological: PembrolizumabALKS 4230 will be administered via SC injection once every 7 or 21 days at escalating doses or at the recommended phase 2 dose and schedule; pembrolizumab will be administered as an intravenous infusion given over 30 minutes; the dose level for pembrolizumab will be 200 mg per the approved label. In December 2020, an RP2D of 3 mg with an administration schedule of q7d was determined for SC ALKS 4230. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types: gastric, ovarian, lung, head and neck.
- Subject must have at least one target lesion based on RECIST
- Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Subjects must have adequate liver function
- Subjects must have adequate kidney function
Key exclusion criteria (9 listed)
- Subject is currently pregnant, planning to become pregnant, or breastfeeding
- Subjects with an active infection or with a fever ≥ 38.5°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 with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
- Subjects who require pharmacologic doses of systemic corticosteroids are excluded; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
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 4230SC injection administered in the back of the arm or the abdomen | Biological | ALKS 4230, ALKS 4230 + pembrolizumab |
| PembrolizumabAlso: KeytrudaAdministered as an intravenous (IV) infusion over 30 minutes | Biological | ALKS 4230 + pembrolizumab |
Primary outcome
Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A
Time frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Includes AEs that are both serious and drug-related
Number of subjects experiencing AEs that are both serious and drug-related in Part B
Time frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Includes AEs that are both serious and drug-related
Clinical Activity of combination treatment with ALKS 4230 and pembrolizumab in each Part B tumor type.
Time frame: From time of therapy until the date of first documented tumor progression, assessed up to 24 months
Overall Response rate (ORR) will be based on investigator review of radiographic and photographic images
10 secondary outcomes
Proportion of subjects with objective evidence of Complete Response (CR)/immune CR (iCR)
Time frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Proportion of subjects with objective evidence of Partial Response (PR)/immune PR (iPR)
Time frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Duration of response in subjects with CR/iCR
Time frame: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Duration of response in subjects with PR/iPR
Time frame: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Non-progression for Part B
Time frame: Assessed up to 24 months
Overall survival for Part B
Time frame: Assessed up to 24 months
Serum concentrations of ALKS 4230 will be determined at various time points
Time frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Serum will be assayed for the presence of anti-ALKS 4230 antibodies
Time frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Time frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points
Time frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- 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.
Mural Oncology Medical Director study director
Mural Oncology
48 sites in 6 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 Pembrolizumab in people with Advanced Solid Tumors, run by Mural Oncology, Inc at 48 sites in 6 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 10 inclusion and 9 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Spain, South Korea, Canada, Taiwan and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A (time frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months). 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?
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 5 Mar 2024.