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Interleukin-2 (IL-2) Agonist

ALKS 4230 for Squamous Cell Carcinoma

Phase 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
Patients must be willing to provide tumor tissue biopsy
Patients must demonstrate adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the first documentation of complete response or partial 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)
Awards & highlights

Study Summary

This trial is testing a new drug combo to see if it can help people with head and neck cancer who haven't responded well to other treatments.

Eligible Conditions
  • Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the first documentation of complete response or partial 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the first documentation of complete response or partial 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with objective evidence of improvement to complete response among those patients who had disease progression at baseline on prior anti-PD-(L)1 therapy
Disease
Proportion of patients with objective evidence of improvement to partial response among those patients who had disease progression at baseline on prior anti-PD-(L)1 therapy
+1 more
Secondary outcome measures
Duration of response in subjects with CR or PR
Incidence of drug-related AEs
Incidence of drug-related AEs leading to discontinuation
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: ALKS 4230 + pembrolizumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
ALKS 4230
2016
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

Mural Oncology, IncLead Sponsor
5 Previous Clinical Trials
989 Total Patients Enrolled
Alkermes, Inc.Lead Sponsor
113 Previous Clinical Trials
26,722 Total Patients Enrolled
Immune Oncology NetworkUNKNOWN
1 Previous Clinical Trials
31 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025