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A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer

Primary Purpose

Non-cutaneous Squamous Cell Carcinoma of Head and Neck

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ALKS 4230

Pembrolizumab

About this trial

This is an interventional treatment trial for Non-cutaneous Squamous Cell Carcinoma of Head and Neck focused on measuring Alkermes, IL-2, Interleukin-2, Oncology, Immuno-oncology, Cytokine Immunotherapy, ALKS 4230, Pembrolizumab, Keytruda, PD-L1, Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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
Patients must have disease that is measurable by RECIST v1.1
Patients must be willing to provide tumor tissue biopsy
Patients must demonstrate adequate organ function
Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication
Patients must agree to follow contraceptive requirements defined in the protocol
Additional criteria apply

Exclusion Criteria:

Patient is pregnant or breastfeeding or expecting to conceive or father children
Patient has an active major infection requiring systemic therapy within 1 week of starting study drug
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
Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (inhaled or topical steroids and steroid replacement at physiologic doses are allowable)
Patient has prior Grade ≥3 immune-related toxicities requiring systemic immunosuppressant treatment that were attributable or possibly attributable to PD-1 immune checkpoint blockade
Patient has active tuberculosis or known active infection with hepatitis B or hepatitis C
Patient has known psychiatric or substance abuse disorders or a social situation that would interfere with cooperation with the requirements of the study
Additional criteria apply

Sites / Locations

Alkermes Investigational Site
Alkermes Investigational Site
Alkermes Investigational Site
Alkermes Investigational Site
Alkermes Investigational Site
Alkermes Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALKS 4230 + pembrolizumab

Arm Description

Outcomes

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

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

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

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

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

Progression-free survival (PFS)

Time to progression

Rate of non-progression (ie, disease control rate) at 6 months

Overall survival

Incidence of drug-related AEs

Incidence of drug-related SAEs

Incidence of drug-related AEs leading to discontinuation

Full Information

NCT ID

NCT04144517

First Posted

October 24, 2019

Last Updated

November 10, 2022

Sponsor

Alkermes, Inc.

Collaborators

Immune Oncology Network

1. Study Identification

Unique Protocol Identification Number

NCT04144517

Brief Title

A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer

Official Title

A Phase 2 Study of ALKS 4230 in Combination With Anti-PD-1 (Pembrolizumab) in Patients With Advanced or Recurrent Head and Neck Squamous Cell Cancer Currently on Treatment With Anti-PD-(L)1 Without Having Achieved a Complete Remission

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

February 5, 2020 (Actual)

Primary Completion Date

October 8, 2021 (Actual)

Study Completion Date

February 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alkermes, Inc.

Collaborators

Immune Oncology Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-cutaneous Squamous Cell Carcinoma of Head and Neck

Keywords

Alkermes, IL-2, Interleukin-2, Oncology, Immuno-oncology, Cytokine Immunotherapy, ALKS 4230, Pembrolizumab, Keytruda, PD-L1, Solid Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALKS 4230 + pembrolizumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ALKS 4230

Intervention Description

Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

Keytruda

Intervention Description

IV infusion over 30 minutes administered on Day 1 of each cycle

Primary Outcome Measure Information:

Title

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

Description

Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1

Time Frame

From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months

Title

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

Description

Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1

Time Frame

From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months

Title

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

Description

Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1

Time Frame

From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months

Title

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

Description

Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1

Time Frame

From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months

Secondary Outcome Measure Information:

Title

Duration of response in subjects with CR or PR

Time Frame

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)

Title

Progression-free survival (PFS)

Time Frame

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)

Title

Time to progression

Time Frame

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)

Title

Rate of non-progression (ie, disease control rate) at 6 months

Time Frame

Assessed PFS at 6 months

Title

Overall survival

Time Frame

Time from first dose of study drug to the time of death (estimated up to 24 months)

Title

Incidence of drug-related AEs

Time Frame

Time from first dose of study drug to the end of study (up to 36 months)

Title

Incidence of drug-related SAEs

Time Frame

Time from first dose of study drug to the end of study (up to 36 months)

Title

Incidence of drug-related AEs leading to discontinuation

Time Frame

Time from first dose of study drug to the end of study (up to 36 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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 Patients must have disease that is measurable by RECIST v1.1 Patients must be willing to provide tumor tissue biopsy Patients must demonstrate adequate organ function Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication Patients must agree to follow contraceptive requirements defined in the protocol Additional criteria apply Exclusion Criteria: Patient is pregnant or breastfeeding or expecting to conceive or father children Patient has an active major infection requiring systemic therapy within 1 week of starting study drug 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 Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (inhaled or topical steroids and steroid replacement at physiologic doses are allowable) Patient has prior Grade ≥3 immune-related toxicities requiring systemic immunosuppressant treatment that were attributable or possibly attributable to PD-1 immune checkpoint blockade Patient has active tuberculosis or known active infection with hepatitis B or hepatitis C Patient has known psychiatric or substance abuse disorders or a social situation that would interfere with cooperation with the requirements of the study Additional criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy Leach, MD

Organizational Affiliation

Alkermes, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Alkermes Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Alkermes Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Alkermes Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Alkermes Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Alkermes Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Alkermes Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78712

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer

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