BridgeMD
A phase 3 study to evaluate petosemtamab vs. investigator's choice in previously treated metastatic / recurrent head and neck cancer.
EU CTIS ID: 2023-510322-32-00
What this study is testing
To compare overall survival (OS) in participants with incurable metastatic / recurrent HNSCC who progressed on or after anti-programmed cell death protein 1 (PD-1) and platinum containing therapy, treated with petosemtamab monotherapy vs Investigator’s choice monotherapy
- Therapeutic confirmatory (Phase III)
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
- 1. Willing and able to provide signed ICF before initiation of any study procedures. Participants unable to provide their own consent will not be eligible to participate in the study.
- 8. The participant is amenable for a new tumor biopsy or providing archival tumor tissue.
- 9. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods
- 12. Adequate organ function (as per protocol)
- 13. Human immunodeficiency virus (HIV)-positive participants.
- 14. Judged appropriate by the Investigator to receive Investigator’s choice monotherapy, if randomized to that treatment arm.
You likely can't join if
- 1. Metastasen in het centraal zenuwstelsel die onbehandeld of symptomatisch zijn, of bestraling, een operatie of voortzetting van steroïdentherapie nodig hebben om de symptomen onder controle te houden binnen 14 dagen vóór randomisatie
- 10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy. History of non-infectious pneumonitis/instestitial lung disease or evidence of current interstitial lung disease on baseline scan
- 11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
- 12. Participants with known infectious diseases (as per protocol)
- 13. Pregnant or breastfeeding participants
- 14. Participant has a primary tumor site of nasopharynx, or sinonasal (any histology).
See the full eligibility criteria
- 1. Willing and able to provide signed ICF before initiation of any study procedures. Participants unable to provide their own consent will not be eligible to participate in the study.
- 8. The participant is amenable for a new tumor biopsy or providing archival tumor tissue.
- 9. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods
- 12. Adequate organ function (as per protocol)
- 13. Human immunodeficiency virus (HIV)-positive participants.
- 14. Judged appropriate by the Investigator to receive Investigator’s choice monotherapy, if randomized to that treatment arm.
- 10. ECOG PS of 0 or 1
- 11. Life expectancy ≥ 12 weeks, as per investigator
- 2. Age ≥ 18 years at signing of ICF
- 3. Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
- 4. HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.
- 5. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- 6. Documentation of p16 status (positive or negative) by local laboratory IHC for participants with primary oropharyngeal cancer must be available before further clinical assessment to determine eligibility.
- 7. Previous treatments with anti-EGFR therapies are not allowed, unless cetuximab was used with radiotherapy as a multimodal treatment of local disease and the recurrence/progression of the disease was ≥1 year from the last dose of cetuximab
- 1. Metastasen in het centraal zenuwstelsel die onbehandeld of symptomatisch zijn, of bestraling, een operatie of voortzetting van steroïdentherapie nodig hebben om de symptomen onder controle te houden binnen 14 dagen vóór randomisatie
- 10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy. History of non-infectious pneumonitis/instestitial lung disease or evidence of current interstitial lung disease on baseline scan
- 11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
- 12. Participants with known infectious diseases (as per protocol)
- 13. Pregnant or breastfeeding participants
- 14. Participant has a primary tumor site of nasopharynx, or sinonasal (any histology).
- 2. Known leptomeningeal involvement
- 3. Enrolled in any clinical study with petosemtamab, regardless if petosemtamab was received or not
- 4. Any systemic anticancer therapy investigational drug (including those with indications other than anticancer therapy), or live or live attenuated vaccine within 4 weeks or 5 half-lives (if known), whichever is shorter, prior to randomization
- 5. Major surgery within 3 weeks prior to randomization or palliative radiotherapy within 2 weeks prior to randomization
- 6. Clinically significant toxicities related to prior antineoplastic therapies that have not returned to ≤ Grade 1 or baseline except for alopecia, and ≤ Grade 2 prior therapy-related endocrinopathies
- 7. History of hypersensitivity reaction to any of the excipients of treatment required for this study.
- 8. Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months prior to randomization
- 9. History of prior malignancies within the last 5 years except for localized cancer with curative resection (e.g., cervical intraepithelial neoplasia, non-melanoma skin cancers)
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- Japan
- Argentina
- Singapore
- Taiwan
- Brazil
- Canada
- Chile
- Australia
- United Kingdom
- Korea, Republic of
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; Japan; Argentina; Singapore; Taiwan and 6 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.