Informations générales (source: ClinicalTrials.gov)
A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
Interventional
Phase 1
Bristol-Myers Squibb (Voir sur ClinicalTrials)
décembre 2022
juillet 2027
20 août 2024
The aim of this study is to assess the safety and tolerability of BMS-986360 as
monotherapy and in combination with chemotherapy or nivolumab in participants with
advanced solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:40 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Santiago PONCE-AIX | 01/07/2024 10:46:37 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Claudius Regaud - 31059 - Toulouse - France | Florence Dalenc, Site 0050 | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13273 - Marseille - Provence-Alpes-Côte-d'Azur - France | Cecile Vicier, Site 0049 | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Participants in Part 1 must have histologic or cytologic confirmation of non-small
cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous
cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal
cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or
sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with
measurable disease per RECIST v1.1. In Part 2, only participants with histologic
confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are
eligible.
- In Part 2, archival biopsy collected within 3 months of screening with no
intervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of
20 freshly cut unstained FFPE slides with an associated pathological report) or
fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1
(C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at
progression. Therefore, the participant in Part 2 must have a suitable tumor lesion
for the biopsy procedure, as judged by the investigator, in order to be eligible for
the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants resistant/refractory to or intolerant of existing standard therapies
known to provide clinical benefit (in addition, participants with NSCLC must be
resistant or refractory to anti-PD-(L)1-based immunotherapy)
- Participants in Part 1 must have histologic or cytologic confirmation of non-small
cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous
cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal
cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or
sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with
measurable disease per RECIST v1.1. In Part 2, only participants with histologic
confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are
eligible.
- In Part 2, archival biopsy collected within 3 months of screening with no
intervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of
20 freshly cut unstained FFPE slides with an associated pathological report) or
fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1
(C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at
progression. Therefore, the participant in Part 2 must have a suitable tumor lesion
for the biopsy procedure, as judged by the investigator, in order to be eligible for
the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants resistant/refractory to or intolerant of existing standard therapies
known to provide clinical benefit (in addition, participants with NSCLC must be
resistant or refractory to anti-PD-(L)1-based immunotherapy)
- Participants with primary central nervous system (CNS) disease, or tumors with CNS
metastases as the only disease site, will be excluded. Participants with controlled
brain metastases, however, will be allowed to enroll. Controlled brain metastases
are defined as no radiographic progression for at least 4 weeks following radiation
and/or surgical treatment (or 4 weeks of observation if no intervention is
clinically indicated), no longer taking steroids for at least 2 weeks prior to first
dose of study intervention, and with no new or progressive neurological signs and
symptoms.
- Participants with a condition requiring systemic treatment with corticosteroids (>
10 mg daily prednisone equivalent) within 14 days or other immunosuppressive
medications within 30 days of randomization. Inhaled or topical steroids and adrenal
replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the
absence of active autoimmune disease.
- Participants with concurrent malignancy or history of prior malignancy active within
2 years (except history of early-stage basal/squamous cell skin cancer or
non-invasive or in situ cancers who have undergone definitive treatment) are
excluded unless treatment was completed at least 2 years before randomization and
the participant has no evidence of disease.
- Participants with NSCLC with known or not tested for epidermal growth factor
receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E
mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1)
translocations sensitive to available targeted inhibitor therapy
Other protocol-defined inclusion/exclusion criteria apply.