Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors

NCT ID: NCT03386721

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-19
• Study Completion Date: 2021-12-30

Brief Summary

This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.

Conditions

Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A (Part I)

Checkpoint Inhibitor (CPI)-Naïve Participants with non-small-cell lung cancer (NSCLC) who have not received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: collection of fresh tumor biopsies (at baseline and on-treatment) will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort B (Part I)

CPI-Experienced Participants (NSCLC) who have received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort C (Part I)

This is a mandatory biopsy cohort based on the treatment's safety and preliminary activity analysis to enroll CPI-Naive Participants. Participants (NSCLC) will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.

Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort D Arm I (Part I)

CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel.

Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.

Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort D Arm 2 (Part I)

CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel.

Participants will receive simlukafusp alfa intravenous (IV) infusion once in 3 weeks (Q3W) up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q3W at a dose of 1200 mg.

Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort D Arm 3 (Part I)

CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel will receive a single-agent gemcitabine or vinorelbine as per approved protocol.

Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Single-agent treatment administered as per approved protocol.

Vinorelbine

Intervention Type: DRUG

Single-agent treatment administered as per approved protocol.

Cohort E Arm I (Part II)

This cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.

Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort E Arm 2 (Part II)

This cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa IV infusion in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg.

Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort F (Part I)

CPI-experienced, docetaxel naive participants (NSCLC) who experienced disease progression during or following treatment with a platinum - containing regimen. Participants will receive combination of simlukafusp alfa and atezolizumab in a Q3W schedule. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg.

Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort G (Part III)

CPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort G Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort H (Part III)

Previously treated, CPI-experienced squamous cell carcinoma head and heck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort H Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort I (Part III)

Previously treated, CPI-naïve squamous esophageal cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort I Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort J (Part III)

Previously treated, CPI-naïve squamous cervical cancer (20 response evaluable participants): mandatory biopsy. Participants in cohort J Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort K (Part III)

CPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort K Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort L (Part III)

Previously treated, CPI-experienced squamous cell carcinoma head and neck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort L Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort M (Part III)

Esophageal SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Cohort N (Part III)

Cervical SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.

Group Type: EXPERIMENTAL

simlukafusp alfa

Intervention Type: DRUG

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Intervention Type: DRUG

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Interventions

simlukafusp alfa

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

Intervention Type: DRUG

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

Intervention Type: DRUG

Gemcitabine

Single-agent treatment administered as per approved protocol.

Intervention Type: DRUG

Vinorelbine

Single-agent treatment administered as per approved protocol.

Intervention Type: DRUG

Other Intervention Names

RO6874281

Eligibility Criteria

Inclusion Criteria

• Participants who have progressed on at least one previous regimen of anticancer therapy (chemotherapy, mutation targeted therapy, and/or CPI therapy)
• Measurable disease, as defined by RECIST Version 1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or Karnofsky Performance Score greater than or equal to (>=) 70
• Life expectancy of >=12 weeks
• Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the treating physician.

Biopsies are not applicable to participants in Cohorts G, H, K, and L presenting with a single target lesion and absence of any non-target lesion.

• Consent to provide an archival tumor tissue sample (if available, applicable to all participants)
• Willingness to undergo baseline and on-treatment tumor biopsies for pharmacodynamics (PD) biomarker analysis (biopsies are optional for Cohort A)
• Adequate cardiovascular function as defined in the study protocol
• AEs related to any previous radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
• Adequate haematological, liver, and renal functions.
• Participants with unilateral pleural effusion (indications other than NSCLC) are eligible if they fulfill both of the following:

1. NYHA Class 1

2. Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) >70% of predicted value; participants with lung metastases should present with DLCO >60% of predicted value.

• Participants with Gilbert's syndrome will be eligible for the study
• Participants must have had confirmed diagnosis of recurrent or metastatic squamous cell carcinoma head and neck, or esophageal cancer or metastatic, persistent or recurrent squamous cervical cancer.

Exclusion Criteria

• Symptomatic or untreated central nervous system (CNS) metastases
• History of treated asymptomatic CNS metastases as described in the protocol
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks before enrollment
• Leptomeningeal disease
• An active second malignancy
• Penetrating tumor infiltration
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
• Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration
• History of significant vascular disease (for example, aortic aneurysm, aortic dissection)
• Active or uncontrolled infections
• Human immunodeficiency virus (HIV) or Active Hepatitis A, B, C, D or E infection (HAV/HBV/HCV/HDV/HEV).
• Severe infection within 4 weeks before study treatment administration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
• History of chronic liver disease or evidence of hepatic cirrhosis
• Dementia or altered mental status that would prohibit informed consent
• History of, active or suspicion of autoimmune disease
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Bilateral pleural effusion confirmed by X-ray
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
• Concurrent therapy with any other investigational drug
• Immunomodulating agents as described in study protocol
• Chronic use of steroids
• Last dose with any cytostatic treatments < 28 days before study treatment administration
• Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy
• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study and 5 months after the last dose of atezolizumab
• Major surgery or significant traumatic injury <28 days before study treatment administration (excluding fine needle biopsies) or if wound healing has not completed after surgery or anticipation of the need for major surgery during study treatment
• Known hypersensitivity to any of the components of the simlukafusp alfa drug product or atezolizumab drug product
• Severe dyspnea at rest or requiring supplementary oxygen therapy Locally curative options are available for participant's disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Cancer Treatment Centers of America

Newnan, Georgia, United States

UZ Antwerpen

Edegem, , Belgium

UZ Gent

Ghent, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

Institut Bergonie

Bordeaux, , France

Hopital Timone Adultes; Oncologie Medicale Et Usp

Marseille, , France

ICM; Medecine B3

Montpellier, , France

Gustave Roussy Cancer Campus

Villejuif, , France

Universitätsklinikum Essen; Innere Klinik (Tumorforschung)

Essen, , Germany

Rambam Medical Center; Oncology

Haifa, , Israel

Auckland City Hospital; Clinical Oncology

Auckland, , New Zealand

Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

Gda?sk, , Poland

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

Warsaw, , Poland

N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

Moscow, , Russia

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

Saint Petersburg, , Russia

National University Hospital; National University Cancer Institute, Singapore (NCIS)

Singapore, , Singapore

National Cancer Centre; Medical Oncology

Singapore, , Singapore

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital del Mar; Servicio de Oncologia

Barcelona, , Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

Clinica Universidad de Navarra Madrid; Servicio de Oncología

Madrid, , Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, , Spain

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, , Spain

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

Madrid, , Spain

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , Spain

Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie

Geneva, , Switzerland

National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

Tainan City, , Taiwan

National Taiwan Uni Hospital; Dept of Oncology

Taipei, , Taiwan

Adana Baskent University Hospital; Medical Oncology

Adana, , Turkey (Türkiye)

Akdeniz University Medical Faculty; Medical Oncology Department

Antalya, , Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, , Turkey (Türkiye)

Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani

Istanbul, , Turkey (Türkiye)

?zmir Medical Park; Onkoloji

Izmir, , Turkey (Türkiye)

Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

Kadiköy, , Turkey (Türkiye)

Barts

London, , United Kingdom

University College London Hospital

London, , United Kingdom

Christie Hospital Nhs Trust; Medical Oncology

Manchester, , United Kingdom

Royal Marsden Hospital; Institute of Cancer Research

Sutton, , United Kingdom

Countries

United States; Belgium; France; Germany; Israel; New Zealand; Poland; Russia; Singapore; South Korea; Spain; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

References

Verlingue L, Italiano A, Prenen H, Guerra Alia EM, Tosi D, Perets R, Lugowska I, Moiseyenko V, Gumus M, Arslan C, Lindsay CR, Deva S, Taus A, Oaknin A, Rottey S, Cicin I, Goksu SS, Smolin A, Rosello-Keranen S, Habigt C, Marbach D, Boetsch C, Dejardin D, Sleiman N, Evers S, Richard M, Ardeshir C, Charo J, Kraxner A, Teichgraber V, Keshelava N, Dziadziuszko R. Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. EBioMedicine. 2024 Nov;109:105374. doi: 10.1016/j.ebiom.2024.105374. Epub 2024 Oct 11.

Reference Type: DERIVED

PMID: 39395231 (View on PubMed)

Prenen H, Deva S, Keam B, Lindsay CR, Lugowska I, Yang JC, Longo F, de Miguel M, Ponz-Sarvise M, Ahn MJ, Gumus M, Champiat S, Italiano A, Salas S, Perets R, Arslan C, Cho BC, Evers S, Boetsch C, Marbach D, Dejardin D, Sleiman N, Ardeshir C, Richard M, Charo J, Kraxner A, Keshelava N, Teichgraber V, Moreno V. Phase II Study to Determine the Antitumor Activity and Safety of Simlukafusp Alfa (FAP-IL2v) Combined with Atezolizumab in Esophageal Cancer. Clin Cancer Res. 2024 Jul 15;30(14):2945-2953. doi: 10.1158/1078-0432.CCR-23-2677.

Reference Type: DERIVED

PMID: 38709220 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-003182-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP40234

Identifier Type: -

Identifier Source: org_study_id