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

NCT03386721 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: BP402342017-003182-94
• Study Type: interventional
• Target: 256
• Locations: 15 countries
• Sites: 44

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.

  Baseline up to disease progression or study treatment discontinuation (up to 38 months)

Secondary Outcomes (9)

• Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1

  Baseline up to disease progression or study treatment discontinuation (up to 38 months)

• Duration of Response (DoR) According to RECIST Version 1.1

  From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months)

• Progression-Free Survival (PFS) According to RECIST Version 1.1

  Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)

• Overall Survival (OS)

  From first dose of study treatment up to death due to any cause (up to approximately 47 months)

• Percentage of Participants With Adverse Events (AEs)

  Baseline up to end of the study (up to approximately 47 months)

Study Arms (17)

Cohort A (Part I)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort B (Part I)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort C (Part I)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort D Arm I (Part I)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort D Arm 2 (Part I)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort D Arm 3 (Part I)

EXPERIMENTAL

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.

Drug: Gemcitabine; Drug: Vinorelbine

Cohort E Arm I (Part II)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort E Arm 2 (Part II)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort F (Part I)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort G (Part III)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort H (Part III)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort I (Part III)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort J (Part III)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort K (Part III)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort L (Part III)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort M (Part III)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Cohort N (Part III)

EXPERIMENTAL

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.

Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Interventions

simlukafusp alfa DRUG

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

Also known as: RO6874281

Cohort A (Part I); Cohort B (Part I); Cohort C (Part I); Cohort D Arm 2 (Part I); Cohort D Arm I (Part I); Cohort E Arm 2 (Part II); Cohort E Arm I (Part II); Cohort F (Part I); Cohort G (Part III); Cohort H (Part III); Cohort I (Part III); Cohort J (Part III); Cohort K (Part III); Cohort L (Part III); Cohort M (Part III); Cohort N (Part III)

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

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

Cohort A (Part I); Cohort B (Part I); Cohort C (Part I); Cohort D Arm 2 (Part I); Cohort D Arm I (Part I); Cohort E Arm 2 (Part II); Cohort E Arm I (Part II); Cohort F (Part I); Cohort G (Part III); Cohort H (Part III); Cohort I (Part III); Cohort J (Part III); Cohort K (Part III); Cohort L (Part III); Cohort M (Part III); Cohort N (Part III)

Gemcitabine DRUG

Single-agent treatment administered as per approved protocol.

Cohort D Arm 3 (Part I)

Vinorelbine DRUG

Single-agent treatment administered as per approved protocol.

Cohort D Arm 3 (Part I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• NYHA Class 1
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (44)

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

San Francisco, California, 94158, United States

Location

Cancer Treatment Centers of America

Newnan, Georgia, 30265, United States

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Hopital Timone Adultes; Oncologie Medicale Et Usp

Marseille, 13385, France

Location

ICM; Medecine B3

Montpellier, 34298, France

Location

Gustave Roussy Cancer Campus

Villejuif, 94805, France

Location

Universitätsklinikum Essen; Innere Klinik (Tumorforschung)

Essen, 45147, Germany

Location

Rambam Medical Center; Oncology

Haifa, 3109601, Israel

Location

Auckland City Hospital; Clinical Oncology

Auckland, 1023, New Zealand

Location

Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

Gda?sk, 80-214, Poland

Location

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

Warsaw, 02-781, Poland

Location

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

Moscow, 105229, Russia

Location

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

Saint Petersburg, 197758, Russia

Location

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

Singapore, 119228, Singapore

Location

National Cancer Centre; Medical Oncology

Singapore, 169610, Singapore

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 003-722, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital del Mar; Servicio de Oncologia

Barcelona, 08003, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Location

Clinica Universidad de Navarra Madrid; Servicio de Oncología

Madrid, 28027, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, 46010, Spain

Location

Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie

Geneva, 1211, Switzerland

Location

National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

Tainan, 704, Taiwan

Location

National Taiwan Uni Hospital; Dept of Oncology

Taipei, 100, Taiwan

Location

Adana Baskent University Hospital; Medical Oncology

Adana, 01120, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty; Medical Oncology Department

Antalya, 07070, Turkey (Türkiye)

Location

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

Edirne, 22030, Turkey (Türkiye)

Location

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

Istanbul, 34098, Turkey (Türkiye)

Location

?zmir Medical Park; Onkoloji

Izmir, Turkey (Türkiye)

Location

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

Kadiköy, 34722, Turkey (Türkiye)

Location

Barts

London, EC1M6BQ, United Kingdom

Location

University College London Hospital

London, N7 9NH, United Kingdom

Location

Christie Hospital Nhs Trust; Medical Oncology

Manchester, M2O 4BX, United Kingdom

Location

Royal Marsden Hospital; Institute of Cancer Research

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39395231 DERIVED

• 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.

  PMID: 38709220 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

atezolizumab; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

08008218590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: December 29, 2017
• Study Start: February 19, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1); TU (6); PL (2); DE (1); BE (3); CH (1); US (2); FR (4); IL (1); TW (2); KR (5); SG (2); ES (8); RU (2); GB (4)