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A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma. (IMCODE001)

Primary Purpose

Advanced Melanoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RO7198457
Pembrolizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Life expectancy >/= 12 weeks;
  • Adequate hematologic and end-organ function;
  • Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions;
  • Tumor specimen availability;
  • Measurable disease per RECIST v1.1.

Exclusion criteria:

  • Ocular/uveal melanoma;
  • Any anti-cancer therapy with the exceptions as specified in the protocol;
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
  • Previous splenectomy;
  • History of autoimmune disease;
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation;
  • Positive test for Human Immunodeficiency Virus (HIV) infection;
  • Active hepatitis B or C or tuberculosis;
  • Significant cardiovascular disease;
  • Known clinically significant liver disease.

Sites / Locations

  • HonorHealth Research Institute ? Bisgrove
  • City of Hope Comprehensive Cancer Center
  • University of California San Diego Moores Cancer Center
  • The Los Angeles Clinic
  • UCSF Comprehensive Cancer Ctr
  • University of Colorado
  • University of Connecticut Health Center
  • Georgetown University
  • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
  • Moffitt McKinley Outpatient Center; McKinley Pharmacy
  • Atlanta Cancer Care
  • Northwestern University
  • Massachusetts General Hospital.
  • Dana Farber Can Ins
  • Washington University; Wash Uni. Sch. Of Med
  • Case Western Research University; University Hospitals Case Medical Center
  • Oregon Health and Science University
  • Sarah Cannon Research Institute
  • Vanderbilt University Medical Center
  • Intermountain Surgical Oncology
  • Intermountain Heathcare/Dixie Regional
  • Huntsman Cancer Institute; University of Utah
  • University of Virginia
  • Seattle Cancer Care Alliance
  • Liverpool Hospital
  • The Queen Elizabeth Hospital; Haematology/Oncology
  • Peter MacCallum Cancer Centre; Medical Oncology
  • Alfred Hospital; Medical Oncology
  • St. John of God - Subiaco Hospital
  • Cliniques Universitaires St-Luc
  • Antwerp University Hospital
  • AZ Groeninge
  • CHU Sart-Tilman
  • Sint Augustinus Wilrijk
  • Elbe Kliniken Stade-Buxtehude GmbH; Klinik für Dermatologie
  • Universitaetsklinikum Erlangen
  • Universitatsklinikum Eppendorf; Klinik fur Dermatologie und Vernerologie
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg; Hauttumorzentrum
  • Universitätsklinikum Koeln
  • Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
  • Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie
  • Fachklinik Hornheide
  • Universitätshautk. Tübingen
  • Clinica Universidad de Navarra
  • Instituto Oncológico Dr. Rosell
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Hospital Clinic de Barcelona
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Universitario La Paz
  • Clinica Universidad de Navarra-Madrid
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Virgen Macarena
  • Fundacion Instituto Valenciano de Oncologia (IVO)
  • Barts and The London
  • The Royal Marsden NHS Foundation Trust; Oncology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Safety Run-in Period: RO7198457 + Pembrolizumab

Randomized Period: Arm A: Pembrolizumab

Randomized Period: Arm B: RO7198457 + Pembrolizumab

Arm Description

Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of RO7198457.

Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with RO7198457 plus pembrolizumab (Arm B) after confirmed disease progression.

Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of RO7198457.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization

Secondary Outcome Measures

Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization
Overall Survival (OS) After Randomization
Duration of Response (DOR) According to RECISTv.1.1 After Randomization
Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization
The 2-item GHS/HRQoL questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) uses a 7-point scale from 1=very poor to 7= excellent. Score range for GHS/HRQoL is 2-14. A negative change from baseline indicates deterioration in GHS.
Mean Change in Physical Function (PF) Score After Randomization
The 5-item PF questionnaire of the EORTC QLQ C30 uses a 4-point scale from 1=not at all to 4=very much. Score range for PF is 5-20. A negative change from baseline indicates deterioration in PF.
Mean Change in Role Function (RF) Score After Randomization
The 2-item RF questionnaire of the EORTC QLQ C30 uses a 4-point scale from 1=not at all to 4=very much. Score range for RF is 2-8. A negative change from baseline indicates deterioration in RF.
Number of Participants With Adverse Events Reported Through the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over
Percentage of Participants With Adverse Events (AEs)

Full Information

First Posted
January 7, 2019
Last Updated
August 2, 2023
Sponsor
Genentech, Inc.
Collaborators
BioNTech SE
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1. Study Identification

Unique Protocol Identification Number
NCT03815058
Brief Title
A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.
Acronym
IMCODE001
Official Title
A Phase II, Open-Label, Multicenter, Randomized Study Of The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab In Patients With Previously Untreated Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
BioNTech SE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety Run-in Period: RO7198457 + Pembrolizumab
Arm Type
Experimental
Arm Description
Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of RO7198457.
Arm Title
Randomized Period: Arm A: Pembrolizumab
Arm Type
Active Comparator
Arm Description
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with RO7198457 plus pembrolizumab (Arm B) after confirmed disease progression.
Arm Title
Randomized Period: Arm B: RO7198457 + Pembrolizumab
Arm Type
Experimental
Arm Description
Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of RO7198457.
Intervention Type
Biological
Intervention Name(s)
RO7198457
Intervention Description
Participants will receive a recommended dose of RO7198457 administered by IV infusion at protocol-defined intervals.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization
Time Frame
The time from randomization to disease progression/death (up to approximately 24 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization
Time Frame
Up to approximately 24 months
Title
Overall Survival (OS) After Randomization
Time Frame
The time from randomization to death from any cause (up to approximately 24 months).
Title
Duration of Response (DOR) According to RECISTv.1.1 After Randomization
Time Frame
The time from randomization up to approximately 24 months.
Title
Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization
Description
The 2-item GHS/HRQoL questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) uses a 7-point scale from 1=very poor to 7= excellent. Score range for GHS/HRQoL is 2-14. A negative change from baseline indicates deterioration in GHS.
Time Frame
From randomization up to approximately 24 months.
Title
Mean Change in Physical Function (PF) Score After Randomization
Description
The 5-item PF questionnaire of the EORTC QLQ C30 uses a 4-point scale from 1=not at all to 4=very much. Score range for PF is 5-20. A negative change from baseline indicates deterioration in PF.
Time Frame
From randomization up to approximately 24 months.
Title
Mean Change in Role Function (RF) Score After Randomization
Description
The 2-item RF questionnaire of the EORTC QLQ C30 uses a 4-point scale from 1=not at all to 4=very much. Score range for RF is 2-8. A negative change from baseline indicates deterioration in RF.
Time Frame
From randomization up to approximately 24 months.
Title
Number of Participants With Adverse Events Reported Through the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame
From randomization up to approximately 24 months.
Title
Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over
Time Frame
Up to 12 months from the time of cross-over
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
Baseline up to 90 days after the final dose of study drug (up to approximately 27 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Life expectancy >/= 12 weeks; Adequate hematologic and end-organ function; Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions; Tumor specimen availability; Measurable disease per RECIST v1.1. Exclusion criteria: Ocular/uveal melanoma; Any anti-cancer therapy with the exceptions as specified in the protocol; Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases; Previous splenectomy; History of autoimmune disease; Prior allogeneic bone marrow transplantation or prior solid organ transplantation; Positive test for Human Immunodeficiency Virus (HIV) infection; Active hepatitis B or C or tuberculosis; Significant cardiovascular disease; Known clinically significant liver disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth Research Institute ? Bisgrove
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
The Los Angeles Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
UCSF Comprehensive Cancer Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Moffitt McKinley Outpatient Center; McKinley Pharmacy
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta Cancer Care
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Can Ins
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University; Wash Uni. Sch. Of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Case Western Research University; University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5067
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Intermountain Surgical Oncology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Intermountain Heathcare/Dixie Regional
City
Saint George
State/Province
Utah
ZIP/Postal Code
84780
Country
United States
Facility Name
Huntsman Cancer Institute; University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22906
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
The Queen Elizabeth Hospital; Haematology/Oncology
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Peter MacCallum Cancer Centre; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Alfred Hospital; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
St. John of God - Subiaco Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Elbe Kliniken Stade-Buxtehude GmbH; Klinik für Dermatologie
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Eppendorf; Klinik fur Dermatologie und Vernerologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Heidelberg; Hauttumorzentrum
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Fachklinik Hornheide
City
Muenster
ZIP/Postal Code
48157
Country
Germany
Facility Name
Universitätshautk. Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Instituto Oncológico Dr. Rosell
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Clinica Universidad de Navarra-Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Fundacion Instituto Valenciano de Oncologia (IVO)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Barts and The London
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust; Oncology
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.

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