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JOURNAL ONKOLOGIE – STUDIE

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

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NCT-Nummer:
NCT04623775

Studienbeginn:
November 2020

Letztes Update:
10.11.2020

Wirkstoff:
Nivolumab, Relatlimab, Carboplatin, Cisplatin, Paclitaxel, Nab-Paclitaxel, Pemetrexed

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Kontakt:
Phone: please email:
E-Mail: Clinical.Trials@bms.com
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First line of the email MUST contain NCT # and Site #.

Studienlocations (3 von 33)

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Studien-Informationen

Brief Summary:

The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in

combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus

relatlimab in combination with PDCT improves progression free survival (PFS) when compared to

nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small

cell lung cancer (NSCLC).

Ein-/Ausschlusskriterien

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please

visit www.BMSStudyConnect.com

Inclusion Criteria:

- Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous

(SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th

International Association for the Study of Lung Cancer Classification) or recurrent

disease following multi-modal therapy for locally advanced disease

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or

equal to 1 at screening and confirmed prior to randomization

- Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI)

per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria

- No prior systemic anti-cancer treatment (including epidermal growth factor receptor

(EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for

advanced or metastatic disease

Exclusion Criteria:

- Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma

proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy

- Untreated CNS metastases

- Leptomeningeal metastases (carcinomatous meningitis)

- Concurrent malignancy requiring treatment or history of prior malignancy active within

2 years prior to enrollment (ie, participants with a history of prior malignancy are

eligible if treatment was completed at least 2 years before registration and the

participant has no evidence of disease)

- Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed

death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic

T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug

specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose (Time Frame - Up to 10 months, from first participant's first dose):
Part 1

2. Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR) (Time Frame - 10 months after randomization, up to 21 months):
Part 2

Secondary outcome:

1. Incidence of TRAEs leading to discontinuation (Time Frame - Up to 10 months, 30 days from participant's last dose):
Part 1

2. Incidence of Serious Adverse Events (SAEs) (Time Frame - Up to 10 months, 30 days from participant's last dose):
Part 1

3. Incidence of select Adverse Events (AEs) (Time Frame - Up to 10 months, 30 days from participant's last dose):
Part 1

4. PFS per RECIST v1.1 by BICR in biomarker subgroups (Time Frame - Until progression, up to 21 months):
Part 2

5. Overall response rate (ORR) per RECIST v1.1 by BICR (Time Frame - Up to 21 months):
Part 2

6. Incidence of Serious Adverse Events (SAEs) (Time Frame - Up to 21 months):
Part 2

7. Incidence of select Adverse Events (AEs) (Time Frame - Up to 21 months):
Part 2

Studien-Arme

  • Experimental: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
  • Experimental: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
  • Experimental: Part 2: Arm C (Nivolumab + Relatlimab Dose 1 or Dose 2 + PDCT)
  • Placebo Comparator: Part 2: Arm D (Nivolumab + Placebo + PDCT)

Geprüfte Regime

  • Nivolumab:
    Specified dose on specified days
  • Relatlimab:
    Specified dose on specified days
  • Carboplatin:
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Cisplatin:
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Paclitaxel:
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Nab-Paclitaxel:
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Pemetrexed:
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Quelle: ClinicalTrials.gov


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