Trial Title:
A Phase 3 Study to Evaluate Petosemtamab Compared with Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
NCT ID:
NCT06496178
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
HNSCC
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Petosemtamab
Description:
MCLA-158
Arm group label:
MCLA-158
Intervention type:
Drug
Intervention name:
Investigator's Choice
Description:
Cetuximab
Arm group label:
Investigator's Choice
Intervention type:
Drug
Intervention name:
Investigator's Choice
Description:
Methotrexate
Arm group label:
Investigator's Choice
Intervention type:
Drug
Intervention name:
Investigator's Choice
Description:
Docetaxel
Arm group label:
Investigator's Choice
Summary:
This is a phase 3 open-label, randomized, controlled, multicenter study to compare
petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and
third-line treatment of incurable metastatic/recurrent disease.
Detailed description:
This is a phase 3 open-label, randomized, controlled, multicenter study to compare
petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and
third-line treatment of incurable metastatic/recurrent disease. HNSCC patients must have
progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy.
Patients treated with platinum-containing therapy only in the adjuvant setting, or in the
context of multimodal therapy for locally advanced disease, should have PD within 6
months of the last dose of platinum-containing therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed ICF before initiation of any study procedures.
- Age ≥ 18 years at signing of ICF.
- Histologically previously confirmed HNSCC with evidence of metastatic or locally
advanced disease not amenable to standard therapy with curative intent.
- HNSCC patients progressed on or after anti-PD-1 therapy and platinum-containing
therapy.
- The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx,
and larynx.
- Documentation of p16 status (positive or negative) by local laboratory IHC for
patients with primary oropharyngeal cancer.
- A baseline new tumor sample unless the patient has an available tumor sample as an
FFPE block with sufficient material.
- Measurable disease as defined by RECIST v1.1 by radiologic methods.
- ECOG PS of 0 or 1
- Life expectancy ≥ 12 weeks, as per investigator
- Adequate organ function (as per protocol)
Exclusion Criteria:
- Central nervous system metastases that are untreated or symptomatic, or require
radiation, surgery, or continued steroid therapy to control symptoms within 14 days
of study entry.
- Known leptomeningeal involvement
- Any systemic anticancer therapy within 4 weeks of the first dose of study treatment.
- Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
- Persistent Grade >1 clinically significant toxicities related to prior
antineoplastic therapies
- History of hypersensitivity reaction to any of the excipients of treatment required
for this study.
- 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 of study entry
- History of prior malignancies with the exception of excised cervical intraepithelial
neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low
risk for recurrence with no evidence of disease
- Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen
therapy
- Current serious illness or medical conditions including, but not limited to,
uncontrolled active infection, clinically significant pulmonary, metabolic or
psychiatric disorders
- Patients with known infectious diseases (as per protocol)
- Pregnant or breastfeeding patients
- Patient has a primary tumor site of nasopharynx (any histology).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Site 25
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 28
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 12
Address:
City:
Bradenton
Zip:
34205
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 9
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 8
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 5
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 18
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 15
Address:
City:
Albuquerque
Zip:
87131
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 24
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 23
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 26
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 7
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 4
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 10
Address:
City:
Blacksburg
Zip:
24060
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 22
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 6
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 30
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Site 3
Address:
City:
Darlinghurst
Country:
Australia
Status:
Recruiting
Facility:
Name:
Site 11
Address:
City:
Saint Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Site 16
Address:
City:
Providencia
Zip:
7500859
Country:
Chile
Status:
Recruiting
Facility:
Name:
Site 20
Address:
City:
Recoleta
Zip:
8420383
Country:
Chile
Status:
Recruiting
Facility:
Name:
Site 27
Address:
City:
Santiago
Zip:
131
Country:
Chile
Status:
Recruiting
Facility:
Name:
Site 21
Address:
City:
Santiago
Zip:
7560908
Country:
Chile
Status:
Recruiting
Facility:
Name:
Site 19
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Site 1
Address:
City:
Jerusalem
Country:
Israel
Status:
Recruiting
Facility:
Name:
Site 2
Address:
City:
Tel Aviv
Country:
Israel
Status:
Recruiting
Facility:
Name:
Site 14
Address:
City:
Tel HaShomer
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Site 29
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site 13
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site 17
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Start date:
June 25, 2024
Completion date:
March 2029
Lead sponsor:
Agency:
Merus N.V.
Agency class:
Industry
Source:
Merus N.V.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496178
