JOURNAL ONKOLOGIE – STUDIE

CAMMA 2

A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05535244

Studienbeginn:
Oktober 2022

Letztes Update:
01.05.2024

Wirkstoff:
Cevostamab, Tocilizumab

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: CO43476 https://forpatients.roche.com
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 33)

CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
12200 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps

Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps

Klinik der Uni zu Köln; Klinik für Innere Medizin
50924 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
97080 Würzburg
(Bayern)
GermanyRekrutierend» Google-Maps

Mayo Clinic - Arizona
85054 Phoenix
United StatesRekrutierend» Google-Maps

University of Colorado
80045-2517 Aurora
United StatesRekrutierend» Google-Maps

Mayo Clinic-Jacksonville
32224 Jacksonville
United StatesRekrutierend» Google-Maps

University of Maryland Greenebaum Cancer Center
21201 Baltimore
United StatesRekrutierend» Google-Maps

Dana Farber Cancer Institute
02215 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps

Mayo Clinic - Rochester
55905 Rochester
United StatesRekrutierend» Google-Maps

Icahn School of Medicine at Mount Sinai (ISMMS); The Derald H. Ruttenberg Treatment Center
10029 New York
United StatesRekrutierend» Google-Maps

Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps

Tennessee Oncology - Nashville
37203 Nashville
United StatesRekrutierend» Google-Maps

Methodist Hospital
78229 San Antonio
United StatesRekrutierend» Google-Maps

Hunstman Cancer Institute
84112 Salt Lake City
United StatesRekrutierend» Google-Maps

Calvary Mater Newcastle; Hematology
2298 Waratah
AustraliaRekrutierend» Google-Maps

St Vincent's Hospital Melbourne
3065 Fitzroy
AustraliaRekrutierend» Google-Maps

UZ Leuven Gasthuisberg
3000 Leuven
BelgiumRekrutierend» Google-Maps

APHP - Hospital Saint Louis
75475 Paris
FranceRekrutierend» Google-Maps

CHU de Poitiers - La Miletrie; Oncologie hematologique - Pole Regional de Cancerologie
86021 Poitiers
FranceRekrutierend» Google-Maps

Hadassah Ein Karem Hospital; Haematology
9112001 Jerusalem
IsraelRekrutierend» Google-Maps

Sheba Medical Center; Tel Hashomer
5262100 Ramat Gan
IsraelRekrutierend» Google-Maps

Sourasky Medical Centre
6423906 Tel-Aviv
IsraelRekrutierend» Google-Maps

Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"
40138 Bologna
ItalyRekrutierend» Google-Maps

ASST PAPA GIOVANNI XXIII; Ematologia
24127 Bergamo
ItalyRekrutierend» Google-Maps

Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia
20133 Milano
ItalyRekrutierend» Google-Maps

A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette; Ematologia I
10126 Torino
ItalyRekrutierend» Google-Maps

Clinica Universitaria de Navarra; Servicio de Hematologia
31008 Pamplona
SpainRekrutierend» Google-Maps

Hospital Clínic i Provincial; Servicio de Hematología y Oncología
08036 Barcelona
SpainRekrutierend» Google-Maps

Clinica Universidad de Navarra Madrid; Servicio de Hematología
28027 Madrid
SpainRekrutierend» Google-Maps

Hospital Univ. 12 de Octubre; Servicio de Hematologia
28041 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario la Fe; Servicio de Hematologia
46026 Valencia
SpainRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in

participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV)

infusion.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Documented diagnosis of MM based on standard International Myeloma Working Group

(IMWG) criteria

- Evidence of progressive disease based on investigators determination of response by

IMWG criteria on or after their last dosing regimen

- Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-T

or ADC therapy and are triple-class relapsed or refractory

- Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting

T-cell-dependent bispecific (TDB) antibody and are triple-class relapsed or refractory

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy is at least 12 weeks

- Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate

samples as detailed in the protocol

- Resolution of AEs from prior anti-cancer therapy to Grade =< 1

- For female participants of childbearing potential: agreement to remain abstinent

(refrain from heterosexual intercourse) or use contraception during the treatment

period and for at least 5 months after the final dose of cevostamab and for 3 months

after the last dose of tocilizumab was administered

- For male participants: agreement to remain abstinent (refrain from heterosexual

intercourse) or use a condom, and agree to refrain from donating sperm during the

treatment period and for at least 2 months after the final dose of tocilizumab (if

applicable) to avoid exposing the embryo

Exclusion Criteria:

- Inability to comply with protocol-mandated hospitalization

- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or

within 5 months after the final dose of cevostamab or tocilizumab or within 3 months

after the last dose of tocilizumab (if applicable)

- Prior treatment with cevostamab or another agent with the same target

- Prior BCMA ADC or CAR-T Cohort: prior treatment with any T cell dependent bi-specific

antibody (TDB) antibody including non BCMA targeting TDB

- Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as

anti-cancer therapy within 4 weeks before first study treatment, except for the use of

non-myeloma therapy

- Prior treatment with systemic immunotherapeutic agents

- Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab

infusion

- Known treatment-related, immune-mediated adverse events associated with prior

checkpoint inhibitors

- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other

anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter,

prior to first study treatment

- Autologous stem cell transplantation (SCT) within 100 days prior to first study

treatment

- Prior allogeneic SCT

- Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheral

blood white cells

- Prior solid organ transplantation

- History of autoimmune disease

- History of confirmed progressive multifocal leukoencephalopathy

- History of severe allergic or anaphylactic reactions to mAb therapy

- Known history of amyloidosis

- Lesions in proximity of vital organs that may develop sudden

decompensation/deterioration in the setting of a tumor flare

- History of other malignancy within 2 years prior to screening, except those with

negligible risk of metastasis or death, such as ductal carcinoma in situ not requiring

chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin

carcinoma, low-grade, localized prostate cancer not requiring treatment or

appropriately treated Stage I uterine cancer

- Current or past history of central nervous system (CNS) disease, such as stroke,

epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM

- Significant cardiovascular disease that may limit a potential participant's ability to

adequately respond to a cytokine release syndrome (CRS) event

- Symptomatic active pulmonary disease or requiring supplemental oxygen

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at

study enrollment, or any major episode of infection requiring treatment with IV

(intravenous) antimicrobials where the last dose of IV antimicrobial was given within

14 days prior to first study treatment

- Active symptomatic COVID-19 infection at study enrollment or requiring treatment with

IV antiviral where the last dose of IV antiviral treatment was given within 14 days

prior to first study treatment. Participants with active COVID-19 infection must have

clinical recovery and two negative antigen tests at least 24 hours apart prior to

first study treatment

- Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or

cytomegalovirus (CMV) PCR prior to first study treatment

- Known or suspected chronic active EBV infection

- Known history of Grade >=3 CRS or immune effector cell-associated neurotoxicity

syndrome (ICANS) with prior bispecific therapies

- Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation

syndrome (MAS)

- Recent major surgery within 4 weeks prior to first study treatment

- Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV)

infection

- Acute or chronic hepatitis C virus (HCV) infection

- Known history of human immunodeficiency virus (HIV) seropositivity

- Administration of a live, attenuated vaccine within 4 weeks before first study

treatment or anticipation that such a live attenuated vaccine will be required during

the study

- Treatment with systemic immunosuppressive medications, with the exception of

corticosteroid treatment <= 10 mg/day prednisone or equivalent, within 2 weeks prior

to first study treatment

- History of illicit drug or alcohol abuse within 12 months prior to screening, in the

investigator's judgment

- Any medical condition or abnormality in clinical laboratory tests that, in the

investigator's judgment, precludes the participant's safe participation in and

completion of the study, or which could affect compliance with the protocol or

interpretation of results

Studien-Rationale

Primary outcome:

1. Objective Response Rate (ORR) as Determined by the Investigator (Time Frame - Baseline up to approximately 2 years)

2. Percentage of Participants with Adverse Events (Time Frame - Baseline up to approximately 2 years)

Secondary outcome:

1. ORR as Determined by the Independent Review Committee (IRC) (Time Frame - Baseline up to approximately 2 years)

2. Duration of Response (DOR) (Time Frame - Baseline up to approximately 2 years)

3. Rate of Complete Response (CR) or Better (Time Frame - Baseline up to approximately 2 years)

4. Rate of Very Good Partial Response (VGPR) or Better (Time Frame - Baseline up to approximately 2 years)

5. Overall Survival (OS) (Time Frame - Baseline up until death from any cause (up to approximately 2 years))

6. Progression-free Survival (PFS) (Time Frame - Baseline up to approximately 2 years)

7. Time to First Response (for Participants who Achieve an Objective Response) (Time Frame - Baseline up to approximately 2 years)

8. Time to Best Response (for Participants who Achieve an Objective Response) (Time Frame - Baseline up to approximately 2 years)

9. Percentage of Participants Experiencing a Clinically Meaningful Improvement in the Fatigue Domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core-30 Questionnaire (QLQ-C30) and EORTC QLQ-MY20 (Time Frame - Baseline up to approximately 2 years)

10. Time to Deterioration in the Fatigue Domain of the EORTC QLQ-C30 and/or Disease Symptoms Domain of the EORTC QLQ-MY20 (Time Frame - Baseline up to approximately 2 years)

11. Serum Concentration of Cevostamab at Specified Timepoints (Time Frame - At Cycles 1, 2, 3, 4, 6, 8 and every other cycle until the end of treatment up to approximately 2 years. Each cycle is 21-days.)

12. Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline (Time Frame - Baseline)

13. Percentage of Participants with ADAs Against Cevostamab During the Study (Time Frame - Up to approximately 2 years)

14. Cytokine Release Syndrome (CRS) Following Administration of Tocilizumab (Time Frame - Baseline up to approximately 2 years)

15. Relationship Between Serum Concentration of Cevostamab and Cytokine Release (Time Frame - Baseline up to approximately 2 years)

16. Relationship Between Serum Concentration of Cevostamab and T Cell Number (Time Frame - Baseline up to approximately 2 years)

17. Relationship Between Serum Concentration of Cevostamab and T-cell Activation State (Time Frame - Baseline up to approximately 2 years)

Studien-Arme

Experimental: Cohort A1: Prior BCMA antibody-drug conjugate (ADC) or chimeric antigen receptor T (CAR-T)
Participants in Cohort A1 will be treated at the double step-up split dosing regimen.
Experimental: Cohort A2: Prior BCMA Bispecific
Participants enrolled into exploratory Cohort A2 will receive the same dosing regimen as Cohort A1.
Experimental: Cohort B1: Prior BCMA CAR-T
Participants enrolled in expansion Cohort B1, will be given cevostamab at the selected dosing regimen.
Experimental: Cohort B2: Prior BCMA Bispecific
Expansion Cohort B2 will be opened, after the initial results from Cohort A2, at the same dose as per Cohort B1.

Geprüfte Regime

Cevostamab:
Cevostamab will be administered by IV infusion in 21-day cycles.
Tocilizumab:
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Quelle: ClinicalTrials.gov

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