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Interleukin-2 (IL-2) Agonist

ALKS 4230 for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by Mural Oncology, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of initiation of therapy until the last treatment cycle, assessed up to 24 months

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe for humans and if they can tolerate it.

Eligible Conditions

Advanced Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of initiation of therapy until the last treatment cycle, assessed up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of initiation of therapy until the last treatment cycle, assessed up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of initiation of therapy until the last treatment cycle, assessed up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Characterization of adverse events (AEs) and dose-limiting toxicities (DLT) in study Part A

Incidence of drug-related AEs in study Part B

Overall response rate (ORR) of ALKS 4230 monotherapy in patients with melanoma or renal cell carcinoma (Part B) and in combination with pembrolizumab in patients with advanced solid tumors (Part C)

Secondary outcome measures

Disease Control Rate

Duration of response in subjects with CR/iCR or PR/iPR

Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: ALKS 4230 + pembrolizumabExperimental Treatment1 Intervention

Group II: ALKS 4230Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALKS 4230

2016

Completed Phase 2

~380

ALKS 4230 + pembrolizumab

2016

Completed Phase 2

~250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mural Oncology, IncLead Sponsor

5 Previous Clinical Trials

760 Total Patients Enrolled

Alkermes, Inc.Lead Sponsor

114 Previous Clinical Trials

26,573 Total Patients Enrolled

Medical DirectorStudy DirectorMural Oncology

2,777 Previous Clinical Trials

8,063,243 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is access to this research initiative currently available for participants?

"At present, this clinical trial is not currently accepting participants. Initially posted on July 1st 2016 and last updated on November 23rd 2022, it is not presently searching for volunteers. However, if you are looking to find other studies that need your help; there are 2503 cancer related trials and 961 trials recruiting patients with ALKS 4230."

Answered by AI

What maladies is ALKS 4230 commonly utilized to treat?

"ALKS 4230 has been found to be a successful treatment for malignant neoplasms and can even help with unresectable melanoma, microsatellite instability high, or disease progression after chemotherapy."

Answered by AI

How many healthcare institutions are conducting this investigation?

"At present, 19 different medical facilities are recruiting participants for this trial. These locations span from Dallas to Montréal and Québec with other sites located in between. To minimize any commuting needed if you join the study, select a clinic closest you."

Answered by AI

Could you provide information on the prior investigations performed utilizing ALKS 4230?

"ALKS 4230 was first investigated by City of Hope in 2010. Currently, there are 249 finished trials and a further 961 ongoing studies based out of Dallas, Texas."

Answered by AI

How many individuals are currently partaking in this clinical experiment?

"This investigation is not currently open to participants. It was initially posted on July 1st, 2016 and most recently revised on November 23rd, 2022. If you are exploring alternatives, there exist 2503 clinical trials actively hunting for cancer patients and 961 studies requiring individuals taking ALKS 4230."

Answered by AI

What results is this trial looking to demonstrate?

"The aim of this research trial, which will be evaluated over the period from drug administration until 30 days after their last dose and up to 24 months, is to assess the overall response rate (ORR) of ALKS 4230 monotherapy in patients with melanoma or renal cell carcinoma (Part B), as well as its efficacy when combined with pembrolizumab for advanced solid tumours (Part C). Secondary objectives include evaluating serum samples for anti-ALKS 4230 antibodies, immunophenotyping peripheral blood mononuclear cells via flow cytometry at various time points, and measuring duration of response in those achieving a"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02799095.