BridgeMD
N/A
EU CTIS ID: 2024-513121-22-00
What this study is testing
To assess the efficacy of domvanalimab and zimberelimab in combination with chemotherapy vs zimberelimab in combination with chemotherapy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be 18 years of age or older and able to understand and give written informed consent.
- Histologically or cytologically confirmed r/m squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
- No prior systemic therapy for r/m HNSCC. Participants who had disease progression or recurrence more than 6 months after the last dose of curative intent systemic platinum containing therapy for locoregionally advanced disease are eligible.
- At least 1 measurable lesion by computed tomography or magnetic resonance imaging that qualifies as a RECIST v1.1 target lesion at baseline. Note: tumor lesions located in a previously irradiated field may be considered measurable if disease progression has been demonstrated in such lesions.
- Have adequate tumor tissue samples preferably from lesions not irradiated prior to biopsy (acceptable from irradiated lesions if disease progression has been demonstrated in such lesions) to submit for central testing of PD-L1 status by investigational for stratification at randomization (Cohort 1 only) and biomarker assessment. Archived tumor tissue samples that were obtained preferably within 24 months prior to the initial dosing (Cycle 1 Day 1) are acceptable but newly acquired samples at baseline are required if archived samples are not available. A fresh biopsy should be taken per standard-of-care practices and only if the attending physician deems it safe. Note: in Cohort 1, PD-L1 expression will be monitored as participant accrual occurs, and if there is a significant difference from the published prevalence, certain PD-L1 expression groups may be prioritized to enroll in the study. Prioritizing certain PD-L1 expression groups will not be implemented until the proper approvals from the Health Authorities have been obtained (IVDR authorization). Note: newly acquired samples at baseline are required (archival tissue samples can be additionally submitted) in Cohort 2.
- Known results from HPV status test (p16 expression) for oropharyngeal carcinoma defined as p16 testing with immunohistochemistry (IHC) assay. HPV testing by polymerase chain reaction (PCR) and in situ hybridization (ISH) can be accepted. If local results by above methods are not available, a tumor tissue sample must be submitted to the designated central laboratory to be tested and p16 status is required prior to randomization. Note: in Cohort 1, documentation of HPV p16 status is required prior to randomization.
You likely can't join if
- Individuals with nasopharyngeal cancer (any histology), squamous cell carcinoma of unknown primary tumors, skin (cutaneous squamous cell carcinoma), paranasal sinuses, and salivary gland.
- Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
- Have known active central nervous system (CNS) metastases. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastasis and are not requiring use of steroid for at least 14 days prior to the first dose of study drugs. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
- Have disease that is suitable for any local therapies with curative intent.
- Individuals who had disease progression or recurrence within 6 months after the last dose of curative intent systemic platinum-containing therapy for locoregionally advanced disease.
- Have a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
See the full eligibility criteria
Who can join
- Participants must be 18 years of age or older and able to understand and give written informed consent.
- Histologically or cytologically confirmed r/m squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
- No prior systemic therapy for r/m HNSCC. Participants who had disease progression or recurrence more than 6 months after the last dose of curative intent systemic platinum containing therapy for locoregionally advanced disease are eligible.
- At least 1 measurable lesion by computed tomography or magnetic resonance imaging that qualifies as a RECIST v1.1 target lesion at baseline. Note: tumor lesions located in a previously irradiated field may be considered measurable if disease progression has been demonstrated in such lesions.
- Have adequate tumor tissue samples preferably from lesions not irradiated prior to biopsy (acceptable from irradiated lesions if disease progression has been demonstrated in such lesions) to submit for central testing of PD-L1 status by investigational for stratification at randomization (Cohort 1 only) and biomarker assessment. Archived tumor tissue samples that were obtained preferably within 24 months prior to the initial dosing (Cycle 1 Day 1) are acceptable but newly acquired samples at baseline are required if archived samples are not available. A fresh biopsy should be taken per standard-of-care practices and only if the attending physician deems it safe. Note: in Cohort 1, PD-L1 expression will be monitored as participant accrual occurs, and if there is a significant difference from the published prevalence, certain PD-L1 expression groups may be prioritized to enroll in the study. Prioritizing certain PD-L1 expression groups will not be implemented until the proper approvals from the Health Authorities have been obtained (IVDR authorization). Note: newly acquired samples at baseline are required (archival tissue samples can be additionally submitted) in Cohort 2.
- Known results from HPV status test (p16 expression) for oropharyngeal carcinoma defined as p16 testing with immunohistochemistry (IHC) assay. HPV testing by polymerase chain reaction (PCR) and in situ hybridization (ISH) can be accepted. If local results by above methods are not available, a tumor tissue sample must be submitted to the designated central laboratory to be tested and p16 status is required prior to randomization. Note: in Cohort 1, documentation of HPV p16 status is required prior to randomization.
What rules you out
- Individuals with nasopharyngeal cancer (any histology), squamous cell carcinoma of unknown primary tumors, skin (cutaneous squamous cell carcinoma), paranasal sinuses, and salivary gland.
- Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
- Have known active central nervous system (CNS) metastases. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastasis and are not requiring use of steroid for at least 14 days prior to the first dose of study drugs. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
- Have disease that is suitable for any local therapies with curative intent.
- Individuals who had disease progression or recurrence within 6 months after the last dose of curative intent systemic platinum-containing therapy for locoregionally advanced disease.
- Have a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Have an active autoimmune disease that required systemic treatment in the past 2 years. (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Prior treatment with any of the following within the specific time frame prior to the first dose of study drug: Major surgery for any cause or significant traumatic injury within 4 weeks prior to the first dose of study drug. Individuals must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study drug. Any noninvestigational anticancer therapy (chemotherapy, biologic therapy, targeted therapy, hormone therapy, or immunotherapy, etc) within 4 weeks prior to the first dose of study drug. Concurrent use for noncancer related condition (eg, hormone replacement therapy) is acceptable. Any investigational drugs (drugs not marketed for any indication) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug. Radiation therapy within 2 weeks prior to the first dose of study drug. Individuals must have recovered to Grade ≤ 1 from all radiation-related oxicities, not requiring corticosteroid, and have not experienced radiation pneumonitis.
- Received prior treatment with any anti-PD-1/PD-L1, anti-TIGIT, or other immune checkpoint inhibitors.
- Currently receiving chronic systemic steroids (> 10 mg/day prednisone or its equivalent). Use of topical, inhalational, intranasal, intraocular steroids, and use as premedication for hypersensitivity reactions (eg, IV contrast allergy) are permitted.
- Any unresolved toxicity (Grade ≥ 2) per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 from prior anticancer therapy or surgical intervention, with the exception of alopecia, vitiligo, and the laboratory toxicities if the laboratory thresholds defined in the inclusion criteria are met. Individuals with Grade ≤ 2 neuropathy are eligible for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- China
- Australia
- Thailand
- Taiwan
- Malaysia
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; China; Australia; Thailand; Taiwan; Malaysia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.