A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PEMBROLIZUMAB PLUS IPILIMUMAB VS PEMBROLIZUMAB PLUS PLACEBO IN PREVIOUSLY UNTREATED, STAGE IV, METASTATIC NON-SMALL CELL LUNG CANCER SUBJECTS WHOSE TUMORS ARE PD-L1 POSITIVE (TPS ≥ 50%) (KEYNOTE-598)

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-035-17
• Date of registration: 04/01/2018
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,
• Public title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PEMBROLIZUMAB PLUS IPILIMUMAB VS PEMBROLIZUMAB PLUS PLACEBO IN PREVIOUSLY UNTREATED, STAGE IV, METASTATIC NON-SMALL CELL LUNG CANCER SUBJECTS WHOSE TUMORS ARE PD-L1 POSITIVE (TPS ≥ 50%) (KEYNOTE-598)
• Scientific title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PEMBROLIZUMAB PLUS IPILIMUMAB VS PEMBROLIZUMAB PLUS PLACEBO IN PREVIOUSLY UNTREATED, STAGE IV, METASTATIC NON-SMALL CELL LUNG CANCER SUBJECTS WHOSE TUMORS ARE PD-L1 POSITIVE (TPS ≥ 50%) (KEYNOTE-598)
• Date of first enrolment: 26/03/2018
• Target sample size: 21
• Recruitment status: Recruiting
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=035-17
• Study type: Interventional
• Study design: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab plus Ipilimumab vs; Pembrolizumab plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung; Cancer Subjects Whose Tumors are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)
• Phase: III

Countries of recruitment

Argentina, Australia, Brazil, Chile, Colombia, France, Germany, Ireland, Italy, Mexico, New Zealand, Poland, Spain, Ukraine, United Kindgdom

Contacts

• Name: Geedy Martel Yllatopa
• Affiliation: MERCK SHARP & DOHME PERU S.R.L

• Name: Angie Guzman Portocarrero
• Affiliation: MERCK SHARP & DOHME PERU S.R.L

Key inclusion & exclusion criteria

Inclusion criteria:
Criterios de Inclusion: Descripcion (sexo, criterios de diagnostico clinico, condiciones co-morbidas, etc. De realizarse el EC con sujetos sanos, consignar, Voluntarios humanos saludables (Español)At least one radiographically measurable lesion per RECIST 1.1.
Be ≥18 years of age
Life expectancy of at least 3 months
Not received prior systemic chemotherapy treatment for their metastatic NSCLC stage IV
Performance status of 0 or 1 (ECOG)
Adequate organ function
Provided formalin fixed tumor tissue from a biopsy of a tumor lesion AFTER the diagnosis of metastatic disease has been made AND from a site not previously irradiate
Histologically or cytologically confirmed diagnosis of metastatic stage IV
Have a PD-L1 positive tumor as determined by IHC
Female subjects must have a negative urine or serum pregnancy test if of childbearing potential or be of non-child bearing potential.
Heterosexually active women are willing to use two methods of birth control (which is also recommended for the female partners of male subjects). The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Subjects should start using birth control from study Visit 1 throughout the study period up to 120 days after the last dose of pembrolizumab and up to 180 days after last dose of chemotherapeutic agents or TKIs
Voluntarily agreed to participate by giving written informed consent

Exclusion criteria:
EGFR sensitizing mutation and/or is EML4/ALK fusion positive
Tumor specimen is not evaluable for PD-L1 expression
Is receiving systemic steroid therapy < 3 days prior to the first study dose
NSCLC can be treated with curative intent with either surgical resection and/or chemo-radiation
Expected to require any other form of systemic or localized antineoplastic therapy while on trial
Received any prior systemic cytotoxic chemotherapy, biological therapy major surgery within 3week of first study dose: radiation therapy of > 30 Gy within 6 months of the first dose; received palliative radiotherapy of 30Gy or less within 7 days of the first dose.
Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Known central nervous system metastases and/or carcinomatous meningitis
Had an allogeneic tissue/solid organ transplant
Active infection, or autoinmune disease
Known history of Human Immunodeficiency Virus, pneumonitis or active Hepatits B or C
Pregnant or breastfeeding, or expecting to conceive or father children. Is currently participating in or has participated in a trial 4 weeks prior to the first dose of trial treatment. Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malignant neoplasm of bronchus and lung

C34

-C34 Malignant neoplasm of bronchus and lung
Malignant neoplasm of bronchus and lung

Intervention(s)

Descripcion de la Intervencion(es): Forma Farmaceutica, dosis, frecuencia, duracion, via de administracion, grupo de tratamiento (Ingles): Treatment Arms: Arma 1: Pembrolizumab 200 mg fixed dose intravenous (IV) every 3 weeks (Q3W) for 35 treatment cycles + ipilimumab 1 mg/kg IV Q6W for 18 treatment cycles, OR Arm 2: Pembrolizumab 200 mg IV Q3W for 35 treatment cycles + placebo IV Q6W for 18 treatment cycles. Subjects treated with pembrolizumab plus ipilimumab or pembrolizumab plus placebo who
attain a confirmed complete response (CR), or who complete 35 administrations of pembrolizumab and 18 treatments of ipilimumab or placebo without demonstrating disease
progression or intolerability to treatment, will stop trial treatment. These subjects may be eligible for retreatment with pembrolizumab only or in combination with ipilimumab or placebo after they have experienced radiographic disease progression at the discretion of the Investigator according to defined criteria in Second Course Phase; this retreatment will be the Second Course Phase. Response or progression in the Second Course Phase will not count towards the ORR and PFS endpoints in this trial.

Secondary ID(s)

03302234

2016-004364-20

Source(s) of Monetary Support

Merck Sharp & Dohme Peru S.R.L.

Ethics review

Status: Approved
Approval date: 19/09/2017
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 30/11/2017
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 15/06/2018
Contact:

[e-mail]

Hospital Nacional Guillermo Almenara Irigoyen - EsSalud

999436950

[e-mail]

Results

• Results available: Yes
• Date Completed: 07/09/2022