- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04439214
Testing Nivolumab as a Potential Targeted Treatment in Cancers With Mismatch Repair Deficiency (MATCH-Subprotocol Z1D)
MATCH Treatment Subprotocol Z1D: Nivolumab in Patients With Tumors With Mismatch Repair Deficiency
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVE:
I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression.
EXPLORATORY OBJECTIVES:
I. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.
II. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.
THE MATCH SCREENING TRIAL:
Please see NCT02465060 for information on the MATCH Screening Protocol and applicable documents.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19103
- ECOG-ACRIN Cancer Research Group
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
- Patients must have mismatch repair deficiency as determined via the MATCH Master Protocol
- Women of childbearing potential (WOCBP) receiving nivolumab must agree to use adequate contraception (hormonal or double barrier method of birth control; abstinence) from one week prior to study treatment starting, during treatment, and for a period of 5 months after the last dose of nivolumab. Men receiving nivolumab and who are sexually active with WOCBP must agree to use adequate contraception (hormonal or double barrier method of birth control; abstinence) from one week prior to study treatment starting, during treatment, and for a period of 7 months after the last dose of nivolumab
Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection may be eligible provided they have the following:
- There must be no evidence of clinically significant hepatic injury from hepatitis virus infection
- For HBV, patients must be on suppressive therapy and have undetectable HBV viral load
- For HCV, patients must either be on suppressive therapy for HCV or have already completed therapy thought to have eradicated HCV
Exclusion Criteria:
- Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition
- No prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti-CTLA-4 antibodies (or any other antibody targeting T cell co-regulatory pathways)
- Patients with cancers for which nivolumab is approved or becomes approved are excluded (e.g: colorectal cancer, locally advanced or metastatic urothelial carcinoma, unresectable or metastatic melanoma, metastatic non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, and recurrent or metastatic squamous cancer of the head and neck)
- Must not have received any of the following therapies within four weeks prior to the first dose of the study drug: IL-2, interferon, or other non-study immunotherapy regimens or immunosuppressive agents
- Must not have a history of toxic epidermal necrolysis (Stevens-Johnson syndrome)
- Must not have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration. Use of such agents while on study is also prohibited. Prior use of growth factors should be documented in the patient's medical history
- Must not have a history of any autoimmune disease: inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis, multiple sclerosis). Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event). Entry of patients with autoimmune diagnoses not listed here must be approved by the protocol chair
- Must not be on supplemental home oxygen
- Must not have evidence of interstitial lung disease
- Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients will be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- No history of severe hypersensitivity reaction to any monoclonal antibody
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Treatment (nivolumab)
Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles.
Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Dato IV
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Overall Response Rate (ORR)
Lasso di tempo: assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression
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Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients.
Best overall response was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients.
The 90% two-sided binomial exact confidence interval was calculated for ORR.
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assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
6-month Progression-free Survival (PFS) Rate
Lasso di tempo: assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression
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PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first.
The 6-month PFS rate was estimated using the Kaplan-Meier method which can provide a point estimate for any specific time point.
Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients.
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assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression
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Progression-free Survival (PFS)
Lasso di tempo: assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression
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PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first.
Median PFS was estimated using the Kaplan-Meier method.
Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients.
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assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nilofer S Azad, ECOG-ACRIN Cancer Research Group
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Neoplasie
- Linfoma
- Mieloma multiplo
- Neoplasie, plasmacellule
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Agenti antineoplastici, immunologici
- Inibitori del checkpoint immunitario
- Nivolumab
Altri numeri di identificazione dello studio
- NCI-2020-03172 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- U10CA180820 (Sovvenzione/contratto NIH degli Stati Uniti)
- U24CA196172 (Sovvenzione/contratto NIH degli Stati Uniti)
- EAY131-Z1D (Altro identificatore: CTEP)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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