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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
nivolumab subcutaneous (BMS-986298)
i
Other names: BMS 986298, ONO4538HSC, ONO 4538HSC, BMS-986298, BMS-986298/rHuPH20, Opdivo SC, ONO-4538HSC, BMS986298
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News alerts, weekly reports and conference planners
Company:
BMS, Ono Pharma
Drug class:
PD1 inhibitor
Related drugs:
3ms
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=31, Recruiting, Ono Pharmaceutical Co. Ltd
New P1 trial • Metastases
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nivolumab subcutaneous (BMS-986298)
4ms
CheckMate 8KX: A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) (clinicaltrials.gov)
P1/2, N=140, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Mar 2025 --> Sep 2024
Trial completion date • Pan tumor
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MSI (Microsatellite instability)
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Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
8ms
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program (clinicaltrials.gov)
P2, N=50, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
Enrollment open
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ABP 206 (nivolumab biosimilar) • nivolumab subcutaneous (BMS-986298)
9ms
CheckMate-6GE: A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection (clinicaltrials.gov)
P3, N=14, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed
Trial completion
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Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
9ms
CheckMate-67T: A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (clinicaltrials.gov)
P3, N=632, Recruiting, Bristol-Myers Squibb | Active, not recruiting --> Recruiting
Enrollment open
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Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
9ms
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program (clinicaltrials.gov)
P2, N=50, Not yet recruiting, Mayo Clinic
New P2 trial
|
ABP 206 (nivolumab biosimilar) • nivolumab subcutaneous (BMS-986298)
11ms
CheckMate-67T: A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (clinicaltrials.gov)
P3, N=632, Active, not recruiting, Bristol-Myers Squibb | N=454 --> 632
Enrollment change
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Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
12ms
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations (clinicaltrials.gov)
P2, N=100, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
Enrollment open
|
Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • nivolumab subcutaneous (BMS-986298)
12ms
Network meta-analysis of global trials of 1L therapies in locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. (ASCO-GI 2024)
A systematic literature review of phase 2, 3, or unknown phase randomized, global trials of 1L therapies (capecitabine + cisplatin [CX]; capecitabine + oxaliplatin [CAPOX]; fluorouracil + cisplatin [CF]; oxaliplatin + folinic acid + fluorouracil [FOLFOX]; S-1 + cisplatin [SC]; nivolumab + CAPOX/FOLFOX; pembrolizumab + CF/CAPOX or CX; and zolbetuximab + CAPOX/FOLFOX) in adults with LA unresectable or mG/GEJ adenocarcinoma... This NMA examined the relative benefit of different targeted therapies when combined with chemotherapy. Zolbetuximab + FOLFOX/CAPOX for CLDN18.2+, HER2−, LA unresectable or mG/GEJ adenocarcinoma confers a significant PFS and OS benefit, similar to that achieved with PD-1/PD-L1 inhibitors + CF/CAPOX or FOLFOX/CAPOX. >*Based on pts in ITT populations regardless of PD-L1 CPS status.
Retrospective data • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
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CLDN18.2 positive + HER-2 negative
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Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb) • Teysuno (gimeracil/oteracil/tegafur) • nivolumab subcutaneous (BMS-986298)
1year
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations (clinicaltrials.gov)
P2, N=100, Not yet recruiting, Bristol-Myers Squibb
New P2 trial
|
Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • nivolumab subcutaneous (BMS-986298)
over1year
CheckMate-6GE: A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection (clinicaltrials.gov)
P3, N=286, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Oct 2026 --> Feb 2024
Trial completion date • Head-to-Head • Metastases
|
Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
almost2years
CheckMate 8KX: A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) (clinicaltrials.gov)
P1/2, N=140, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Mar 2025 | Trial primary completion date: Nov 2023 --> Sep 2022
Enrollment closed • Trial completion date • Trial primary completion date • Pan tumor
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
over2years
CheckMate 8KX: A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) (clinicaltrials.gov)
P1/2, N=170, Recruiting, Bristol-Myers Squibb | Trial primary completion date: Oct 2022 --> Nov 2023
Trial primary completion date • Pan tumor
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
over3years
CheckMate 8KX: A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) (clinicaltrials.gov)
P1/2, N=170, Recruiting, Bristol-Myers Squibb | N=60 --> 170 | Trial completion date: Oct 2024 --> Jul 2025 | Trial primary completion date: Sep 2021 --> Oct 2022
Enrollment change • Trial completion date • Trial primary completion date • Pan tumor
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
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