A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer
Study Details
Study Description
Brief Summary
The primary objective of this study is to estimate the response rate to ALKS 4230 in combination with pembrolizumab in patients with HNSCC who have previously received anti-PD-(L)1 therapy but who have not achieved a CR.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ALKS 4230 + pembrolizumab
|
Drug: ALKS 4230
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
Drug: Pembrolizumab
IV infusion over 30 minutes administered on Day 1 of each cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with objective evidence of improvement to partial response among those patients who had stable disease at baseline on prior anti-PD-(L)1 therapy [From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months]
Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1
- Proportion of patients with objective evidence of improvement to complete response among those patients who had stable disease or partial response at baseline on prior anti-PD-(L)1 therapy [From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months]
Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1
- 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 [From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months]
Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1
- 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 [From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months]
Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1
Secondary Outcome Measures
- Duration of response in subjects with CR or PR [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)]
- Progression-free survival (PFS) [Time from first dose of study drug to the time of first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)]
- Time to progression [Time from first dose of study drug to the time of first documentation of objective tumor progression or death due to disease progression (estimated up to 24 months)]
- Rate of non-progression (ie, disease control rate) at 6 months [Assessed PFS at 6 months]
- Overall survival [Time from first dose of study drug to the time of death (estimated up to 24 months)]
- Incidence of drug-related AEs [Time from first dose of study drug to the end of study (up to 36 months)]
- Incidence of drug-related SAEs [Time from first dose of study drug to the end of study (up to 36 months)]
- Incidence of drug-related AEs leading to discontinuation [Time from first dose of study drug to the end of study (up to 36 months)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must have histologically or cytopathologically confirmed diagnosis of non-cutaneous squamous cell carcinoma of the head and neck region that is locally advanced and/or recurrent and no longer amenable to local surgical or radiation therapy and/or with evidence of distant metastatic disease
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Patients must have had anti-PD-(L)1 therapy as the most recent systemic therapy with either stable disease or partial response on prior anti-PD-(L)1 therapy, or progressive disease on prior anti-PD-(L)1 therapy
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Patients must have disease that is measurable by RECIST v1.1
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Patients must be willing to provide tumor tissue biopsy
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Patients must demonstrate adequate organ function
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Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication
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Patients must agree to follow contraceptive requirements defined in the protocol
-
Additional criteria apply
Exclusion Criteria:
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Patient is pregnant or breastfeeding or expecting to conceive or father children
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Patient has an active major infection requiring systemic therapy within 1 week of starting study drug
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Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate, provided that they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study drug
-
Patient has hypersensitivity to pembrolizumab, ALKS 4230, or any of their excipients
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Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (inhaled or topical steroids and steroid replacement at physiologic doses are allowable)
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Patient has prior Grade ≥3 immune-related toxicities requiring systemic immunosuppressant treatment that were attributable or possibly attributable to PD-1 immune checkpoint blockade
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Patient has active tuberculosis or known active infection with hepatitis B or hepatitis C
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Patient has known psychiatric or substance abuse disorders or a social situation that would interfere with cooperation with the requirements of the study
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Additional criteria apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alkermes Investigational Site | Miami | Florida | United States | 33136 |
| 2 | Alkermes Investigational Site | Atlanta | Georgia | United States | 30308 |
| 3 | Alkermes Investigational Site | Minneapolis | Minnesota | United States | 55455 |
| 4 | Alkermes Investigational Site | New York | New York | United States | 10029 |
| 5 | Alkermes Investigational Site | Cleveland | Ohio | United States | 44195 |
| 6 | Alkermes Investigational Site | Austin | Texas | United States | 78712 |
Sponsors and Collaborators
- Alkermes, Inc.
- Immune Oncology Network
Investigators
- Study Director: Timothy Leach, MD, Alkermes, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ION-01-ALKS 4230