Trial Title:
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Head and Neck Cancer
NCT ID:
NCT06525220
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab
Conditions: Keywords:
HNSCC
PD-L1+
Head and Neck cancer
Petosemtamab
Pembrolizumab
Liger
Oral Cavity
Oropharynx
Larynx
Hypopharynx
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:
Petosemtamab + Pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Humanized Antibody
Arm group label:
Pembrolizumab
Arm group label:
Petosemtamab + Pembrolizumab
Summary:
This is Phase 3 randomized, open-label study to evaluate the efficacy and safety of
petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or
metastatic PD-L1+ head and neck squamous cell carcinoma.
Detailed description:
This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of
petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or
metastatic PD-L1+ HNSCC. HNSCC patients should not have had previous systemic therapy
administered in the recurrent or metastatic setting, although previous systemic therapy
as part of multimodal treatment for locally advanced disease is allowed if PD was ≥6
months after the last platinum-containing therapy dose. Previous treatments with anti
PD-(L)1 or anti-EGFR therapies are not allowed. In the case of cetuximab, patients who
have received cetuximab with radiotherapy as a local treatment and PD was >1 year after
the last dose of cetuximab are eligible.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed ICF before initiation of any study procedures
2. Age ≥ 18 years at signing of ICF
3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent
disease not amenable to local therapy with curative intent.
4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx,
and larynx.
5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors
expressing PD-L1, CPS ≥1.
6. HNSCC patients should not have had previous systemic therapy administered in the
incurable recurrent or metastatic setting
7. A baseline new tumor sample unless the patient has an available tumor sample as an
FFPE block with sufficient material.
8. Measurable disease as defined by RECIST v1.1 by radiologic methods.
9. ECOG Performance Status (PS) of 0-1
10. Life expectancy ≥ 12 weeks, as per investigator assessment.
11. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit,
whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
12. Adequate organ function as defined per protocol.
Exclusion Criteria:
1. Central nervous system metastases that are untreated or already treated but
symptomatic, or require radiation, surgery, or continued steroid therapy to control
symptoms within 21 days of study entry.
2. Known leptomeningeal involvement
3. Any systemic anticancer therapy within 4 weeks of the first dose of study treatment
4. Major surgery or radiotherapy within 3 weeks of the first dose of study treatment
5. Persistent Grade >1 clinically significant toxicities related to prior cancer
therapies (except for alopecia); stable sensory neuropathy Grade ≤2 National Cancer
Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 is
allowed.
6. History of hypersensitivity reaction to any of the excipients of petosemtomab or
pembrolizumab.
7. 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
8. History of prior malignancies, with the exception of excised local cancer, or
treated cancer deemed at low risk for recurrence with no evidence of disease for ≥3
years
9. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen
therapy
10. Current serious illness or medical conditions including, but not limited to,
uncontrolled active infection, clinically significant pulmonary, metabolic or
psychiatric disorders
11. Patients with known infectious diseases as per protocol.
12. Pregnant or breastfeeding patients.
13. The patient has a diagnosis of immunodeficiency or is receiving systemic steroid
therapy or any form of immunosuppressive therapy within 7 days prior to the first
dose
14. The patient has an active autoimmune disease that has required systemic immune
suppressive treatment in the past 2 years; replacement therapy is not considered
immune suppressive treatment.
15. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any
histology)
Other protocol defined inclusion/exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Site 27
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 16
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 19
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 14
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 8
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 21
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 20
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 2
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 6
Address:
City:
Albuquerque
Zip:
87102
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 22
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 1
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 18
Address:
City:
Plano
Zip:
75075
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 17
Address:
City:
Sugarland
Zip:
77479
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 15
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 10
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 12
Address:
City:
Blacksburg
Zip:
24060
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 23
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 30
Address:
City:
La Rioja
Zip:
5300
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Site 11
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Facility:
Name:
Site 24
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Site 26
Address:
City:
Providencia
Zip:
7500859
Country:
Chile
Status:
Recruiting
Facility:
Name:
Site 29
Address:
City:
Recoleta
Zip:
8420000
Country:
Chile
Status:
Recruiting
Facility:
Name:
Site 25
Address:
City:
Temuco
Zip:
76281055-7
Country:
Chile
Status:
Recruiting
Facility:
Name:
Site 9
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Site 5
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Facility:
Name:
Site 3
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Site 7
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
Site 13
Address:
City:
Gyeonggi-do
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site 28
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site 4
Address:
City:
Kaohsiung City
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Start date:
September 25, 2024
Completion date:
July 2030
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/NCT06525220
