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Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06062420
Recruitment Status : Recruiting
First Posted : October 2, 2023
Last Update Posted : January 22, 2024
Sponsor:
Collaborator:
iTeos Therapeutics
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).

Condition or disease Intervention/treatment Phase
Neoplasms, Head and Neck Drug: Dostarlimab Drug: Belrestotug Drug: GSK6097608 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
Actual Study Start Date : November 14, 2023
Estimated Primary Completion Date : September 17, 2025
Estimated Study Completion Date : August 12, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Dostarlimab

Arm Intervention/treatment
Experimental: Dostarlimab Monotherapy Drug: Dostarlimab
Dostarlimab will be administered.

Experimental: Sub study 1: Dostarlimab and Belrestotug Drug: Dostarlimab
Dostarlimab will be administered.

Drug: Belrestotug
Belrestotug will be administered.

Experimental: Sub study 2: Dostarlimab and GSK6097608 Drug: Dostarlimab
Dostarlimab will be administered.

Drug: GSK6097608
GSK6097608 will be administered.

Experimental: Sub study 3: Dosarlimab and Belrestotug and GSK6097608 Drug: Dostarlimab
Dostarlimab will be administered.

Drug: Belrestotug
Belrestotug will be administered.

Drug: GSK6097608
GSK6097608 will be administered.




Primary Outcome Measures :
  1. Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy [ Time Frame: Up to approximately 24 months ]
    Confirmed ORR is defined as the percentage of participants achieving confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.


Secondary Outcome Measures :
  1. Overall Survival (OS) compared between Sub studies and Dostarlimab monotherapy [ Time Frame: Up to approximately 24 months ]
    OS is defined as the time from the date of randomization to the date of death due to any cause.

  2. Duration of Response (DOR) compared between Sub studies and Dostarlimab monotherapy [ Time Frame: Up to approximately 24 months ]
    DOR per RECIST 1.1 by investigator assessment, defined as the time from the date of first documented objective response (CR or PR) to the date of first documented Disease progression (PD) or death due to any cause, whichever comes first.

  3. Progression Free Survival (PFS) compared between Sub studies and Dostarlimab monotherapy [ Time Frame: Up to approximately 24 months ]
    PFS per RECIST 1.1 by investigator assessment, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first.

  4. Disease Control Rate (DCR) compared between Sub studies and Dostarlimab monotherapy [ Time Frame: Up to approximately 24 months ]
    DCR is defined as the percentage of participants achieving CR or PR, or Stable disease (SD) greater than or equal to (≥) 6 months, per RECIST 1.1 by investigator assessment.

  5. Rate of Circulating Tumor Deoxyribonucleic Acid (ctDNA) Molecular Response [ Time Frame: Up to approximately 24 months ]
    The rate of ctDNA molecular response, is defined as the percentage of participants achieving a ≥50% decrease in ctDNA level compared to baseline, measured by plasma ctDNA assessment

  6. Confirmed Objective Response Rate (ORR) compared between Sub study 3 and Sub studies 1 and 2 [ Time Frame: Up to approximately 24 months ]
    Confirmed ORR is defined as the percentage of participants achieving confirmed CR or PR per RECIST version 1.1 by investigator assessment.

  7. Overall Survival (OS) compared between Sub study 3 and Sub studies 1 and 2 [ Time Frame: Up to approximately 24 months ]
    OS is defined as the time from the date of randomization to the date of death due to any cause.

  8. Duration of Response (DOR) compared between Sub study 3 and Sub studies 1 and 2 [ Time Frame: Up to approximately 24 months ]
    DOR per RECIST v 1.1 by investigator assessment, defined as the time from the date of first documented objective response (CR or PR) to the date of first documented PD or death due to any cause, whichever comes first.

  9. Progression Free Survival (PFS) compared between Sub study 3 and Sub studies 1 and 2 [ Time Frame: Up to approximately 24 months ]
    PFS per RECIST 1.1 by investigator assessment, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first.

  10. DCR compared between sub study 3 and Sub studies 1 and 2 [ Time Frame: Up to approximately 24 months ]
    DCR is defined as the percentage of participants achieving CR or PR, or Stable disease (SD) ≥ 6 months, per RECIST v1.1 by investigator assessment.

  11. Rate of ctDNA Molecular Response compared between sub study 3 and Sub studies 1 and 2 [ Time Frame: Up to approximately 24 months ]
  12. Number of Participants with Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) [ Time Frame: Up to approximately 24 months ]
  13. Number of Participants with TEAEs or SAEs leading to dose modifications or study intervention discontinuation [ Time Frame: Up to approximately 24 months ]
  14. Number of Participants with Clinically Significant Findings in Physical examination, Vital signs, Electrocardiogram (ECG), Echocardiogram (ECHO), Multigated acquisition (MUGA) and Laboratory test parameters [ Time Frame: Up to approximately 24 months ]
  15. Number of Participants with Anti-Drug Antibodies (ADA) against Dostarlimab [ Time Frame: Up to approximately 24 months ]
  16. Number of Participants with Anti-Drug Antibodies (ADA) against Belrestotug [ Time Frame: Up to approximately 24 months ]
  17. Number of Participants with Anti-Drug Antibodies (ADA) against GSK6097608 [ Time Frame: Up to approximately 24 months ]
  18. Maximum Concentration (Cmax) and Minimum Concentration (Cmin) of Dostarlimab [ Time Frame: Up to approximately 24 months ]
  19. Cmax and Cmin of Belrestotug [ Time Frame: Up to approximately 24 months ]
  20. Cmax and Cmin of GSK6097608 [ Time Frame: Up to approximately 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies. A) Subjects must not have had prior systemic therapy administered in the R/M setting. Chemoradiation therapy which was completed more than 4 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed B) The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primary tumor site of nasopharynx (any histology)
  • Has measurable (target) disease based on RECIST 1.1 as determined by the investigator.
  • Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. Although a fresh tumor tissue sample obtained within 90 days of screening is highly preferred, an archival tumor specimen (≤2 years old) is acceptable. Biopsies obtained prior to the administration of any systemic therapy administered for the treatment of a participant's tumor (such as neoadjuvant/adjuvant therapy) are not acceptable. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen is not acceptable.
  • Has tumor Programmed death ligand 1 (PD-L1) expression
  • If the primary tumor site is oropharyngeal carcinoma, the participant must have Human papillomavirus (HPV) results

Exclusion Criteria:

  • Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine based inhibitory motif domains (TIGIT), Cluster of differentiation (CD) 96, or other immune checkpoint pathways.
  • Participants with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
  • Have active tumor bleeding or a high risk of bleeding (examples include but are not limited to radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major vessel [carotid, jugular, bronchial artery] and/or exhibits other high-risk features such as arteriovenous fistula).
  • Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC
  • Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic Central Nervous System (CNS) metastases
  • Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years. (Stable, medically managed autoimmune endocrinopathies are acceptable if participant otherwise meets entry criteria.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06062420


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Sponsors and Collaborators
GlaxoSmithKline
iTeos Therapeutics
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT06062420    
Other Study ID Numbers: 219885
2023-503428-24-00 ( Other Identifier: European Medicines Agency )
First Posted: October 2, 2023    Key Record Dates
Last Update Posted: January 22, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Dostarlimab
Belrestotug
GSK6097608
PD-L1
HNSCC
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Dostarlimab
Antineoplastic Agents