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DRUG:

ABP 206 (nivolumab biosimilar)

i
Other names: ABP 206, ABP-206, ABP206
Associations
Company:
Amgen
Drug class:
PD1 inhibitor
Related drugs:
Associations
3d
A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC) (clinicaltrials.gov)
P2, N=15, Active, not recruiting, National Cancer Institute (NCI) | N=40 --> 15 | Trial completion date: Sep 2027 --> Nov 2025 | Trial primary completion date: Sep 2027 --> Sep 2024
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD38 (CD38 Molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD69 (CD69 Molecule) • TFE3 (Transcription Factor Binding To IGHM Enhancer 3) • CD14 (CD14 Molecule) • CD24 (CD24 Molecule) • ITGAM (Integrin, alpha M) • FOXP3 (Forkhead Box P3)
|
PD-L1 expression • PD-1 expression • TFEB translocation
|
Opdivo (nivolumab) • Inlyta (axitinib) • ABP 206 (nivolumab biosimilar)
14d
Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=117, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
KRAS G12C • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • ALK rearrangement • EGFR L861Q • ROS1 positive • KRAS G12 • EGFR exon 20 mutation • MET positive • EGFR negative
|
Opdivo (nivolumab) • gemcitabine • docetaxel • Cabometyx (cabozantinib tablet) • albumin-bound paclitaxel • Cyramza (ramucirumab) • Cometriq (cabozantinib capsule) • ABP 206 (nivolumab biosimilar)
14d
Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial (clinicaltrials.gov)
P2, N=82, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Aug 2024 --> Oct 2025 | Trial primary completion date: Aug 2024 --> May 2024
Trial completion date • Trial primary completion date • Minimal residual disease
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • ABP 206 (nivolumab biosimilar)
14d
DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
P3, N=300, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Metastases
|
BRAF mutation • BRAF V600
|
THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
|
Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
19d
Enrollment change • Combination therapy • Checkpoint inhibition
|
CD19 (CD19 Molecule)
|
CD19 expression
|
Opdivo (nivolumab) • cytarabine • Blincyto (blinatumomab) • methotrexate • vincristine • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Hemady (dexamethasone tablets) • ABP 206 (nivolumab biosimilar) • Asparec (PEGylated recombinant Erwinia chrysantemi-derived L-asparaginase) • Starasid (cytarabine ocfosfate) • dexamethasone injection
21d
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study (clinicaltrials.gov)
P3, N=1175, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • ABP 206 (nivolumab biosimilar)
1m
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers (clinicaltrials.gov)
P1, N=12, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025
Trial completion date • Checkpoint inhibition • Checkpoint block • Metastases
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
|
BRAF mutation
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • prednisone • ABP 206 (nivolumab biosimilar)
1m
Trial completion date • Combination therapy • Checkpoint inhibition • IO biomarker
|
CD19 (CD19 Molecule) • CD34 (CD34 molecule) • MME (Membrane Metalloendopeptidase)
|
CD19 expression
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Blincyto (blinatumomab) • ABP 206 (nivolumab biosimilar)
1m
Enrollment open • Tumor mutational burden • IO biomarker • Metastases
|
TMB (Tumor Mutational Burden) • CD68 (CD68 Molecule)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • ABP 206 (nivolumab biosimilar)
1m
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma (clinicaltrials.gov)
P3, N=249, Recruiting, Amgen | Trial completion date: Jul 2025 --> Nov 2025 | Trial primary completion date: Jul 2025 --> Nov 2025
Trial completion date • Trial primary completion date • Metastases
|
Opdivo (nivolumab) • ABP 206 (nivolumab biosimilar)
1m
S14-00011: Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (clinicaltrials.gov)
P1/2, N=146, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
Enrollment closed
|
PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • LGALS1 (Galectin 1) • ICOS (Inducible T Cell Costimulator)
|
TNFRSF8 expression
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Adcetris (brentuximab vedotin) • ABP 206 (nivolumab biosimilar)
1m
S2107: Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation (clinicaltrials.gov)
P2, N=84, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2025 --> Feb 2026 | Trial primary completion date: Aug 2024 --> Feb 2026
Trial completion date • Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF V600E • BRAF V600
|
Opdivo (nivolumab) • Erbitux (cetuximab) • Braftovi (encorafenib) • ABP 206 (nivolumab biosimilar)
2ms
S2107: Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation (clinicaltrials.gov)
P2, N=86, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Aug 2024 --> Oct 2025
Enrollment closed • Trial completion date
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF V600E • BRAF V600
|
Opdivo (nivolumab) • Erbitux (cetuximab) • Braftovi (encorafenib) • ABP 206 (nivolumab biosimilar)
2ms
EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients (clinicaltrials.gov)
P3, N=205, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
Enrollment closed • Checkpoint inhibition • Metastases
|
CD4 (CD4 Molecule)
|
Opdivo (nivolumab) • carboplatin • paclitaxel • ABP 206 (nivolumab biosimilar)
2ms
Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov)
P1, N=95, Terminated, National Cancer Institute (NCI) | Trial completion date: Sep 2025 --> Aug 2024 | Active, not recruiting --> Terminated; Inadequate accrual rate
Trial completion date • Trial termination
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
2ms
Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov)
P1, N=95, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Aug 2024 --> Sep 2025 | Trial primary completion date: Aug 2024 --> May 2024
Enrollment closed • Trial completion date • Trial primary completion date • Surgery • Metastases
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
2ms
Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=117, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
KRAS G12C • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • ALK rearrangement • EGFR L861Q • ROS1 positive • KRAS G12 • EGFR exon 20 mutation • MET positive • EGFR negative
|
Opdivo (nivolumab) • gemcitabine • docetaxel • Cabometyx (cabozantinib tablet) • albumin-bound paclitaxel • Cyramza (ramucirumab) • Cometriq (cabozantinib capsule) • ABP 206 (nivolumab biosimilar)
2ms
Enrollment open • Mismatch repair
|
MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
MSI-H/dMMR
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
2ms
Trial completion date • IO biomarker • Surgery • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CD86 (CD86 Molecule)
|
HR positive • HER-2 negative
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Jingzhuda (entinostat) • ABP 206 (nivolumab biosimilar)
3ms
Phase classification • Combination therapy • Metastases
|
BRAF (B-raf proto-oncogene)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • sirolimus • ABP 206 (nivolumab biosimilar)
3ms
AIM-NIVO: Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer (clinicaltrials.gov)
P1, N=300, Recruiting, National Cancer Institute (NCI) | Trial completion date: Aug 2024 --> Aug 2026 | Trial primary completion date: Aug 2024 --> Aug 2026
Trial completion date • Trial primary completion date • Metastases
|
MSI (Microsatellite instability) • IL2 (Interleukin 2)
|
Opdivo (nivolumab) • ABP 206 (nivolumab biosimilar)
3ms
Enrollment open • Combination therapy • IO biomarker • Metastases
|
Opdivo (nivolumab) • avutometinib (VS-6766) • defactinib (VS-6063) • ABP 206 (nivolumab biosimilar)
3ms
Trial suspension • Mismatch repair
|
MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
4ms
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer (clinicaltrials.gov)
P3, N=636, Suspended, National Cancer Institute (NCI) | Active, not recruiting --> Suspended
Trial suspension • Tumor mutational burden • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • cisplatin • ABP 206 (nivolumab biosimilar)
4ms
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer (clinicaltrials.gov)
P3, N=636, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
Enrollment closed • Tumor mutational burden • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • cisplatin • ABP 206 (nivolumab biosimilar)
4ms
Phase classification • Combination therapy • Metastases
|
BRAF (B-raf proto-oncogene)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • sirolimus • ABP 206 (nivolumab biosimilar)
4ms
SWOG S1609: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors (clinicaltrials.gov)
P2, N=818, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2033 --> May 2026 | Trial primary completion date: May 2033 --> May 2026
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
4ms
SWOG S1609: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors (clinicaltrials.gov)
P2, N=818, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> May 2033 | Trial primary completion date: May 2026 --> May 2033
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
4ms
New P2 trial • Combination therapy • IO biomarker • Metastases
|
Opdivo (nivolumab) • avutometinib (VS-6766) • defactinib (VS-6063) • ABP 206 (nivolumab biosimilar)
5ms
Enrollment change
|
PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • ABP 206 (nivolumab biosimilar)
5ms
Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers (clinicaltrials.gov)
P2, N=68, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2024 --> Sep 2025 | Trial primary completion date: Jun 2024 --> Sep 2025
Trial completion date • Trial primary completion date • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • NECTIN1 (Nectin Cell Adhesion Molecule 1)
|
Opdivo (nivolumab) • Imlygic (talimogene laherparepvec) • ABP 206 (nivolumab biosimilar)
6ms
Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=1, Active, not recruiting, National Cancer Institute (NCI) | N=13 --> 1 | Trial completion date: Feb 2025 --> Jun 2025
Enrollment change • Trial completion date • Combination therapy • Tumor mutational burden
|
TP53 (Tumor protein P53)
|
Opdivo (nivolumab) • Venclexta (venetoclax) • decitabine • ABP 206 (nivolumab biosimilar)
6ms
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov)
P3, N=244, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2028 --> Sep 2027 | Trial primary completion date: Dec 2028 --> Sep 2027
Trial completion date • Trial primary completion date • Combination therapy
|
Opdivo (nivolumab) • Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • Truxima (rituximab-abbs) • Rituxan Hycela (rituximab/hyaluronidase) • Neulasta (pegfilgrastim) • ABP 206 (nivolumab biosimilar) • Mabtas (rituximab biosimilar) • Neupogen (filgrastim) • prednisolone
6ms
PARAMMUNE: Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial (clinicaltrials.gov)
P2/3, N=224, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Opdivo (nivolumab) • paclitaxel • Cyramza (ramucirumab) • ABP 206 (nivolumab biosimilar)
6ms
Phase classification
|
Signatera™
|
Opdivo (nivolumab) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar)
6ms
Enrollment closed • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • ABP 206 (nivolumab biosimilar)
6ms
A Study Using a New Drug, Nivolumab, in Combination With Chemotherapy Drugs to Treat a Type of Cancer Called Nasopharyngeal Carcinoma (NPC) (clinicaltrials.gov)
P2, N=50, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jan 2025
Enrollment open • Trial initiation date • Combination therapy
|
Opdivo (nivolumab) • cisplatin • gemcitabine • ABP 206 (nivolumab biosimilar)
6ms
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, The PARAMMUNE Trial (clinicaltrials.gov)
P2/3, N=224, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Jun 2024 --> Jan 2025
Trial initiation date • Metastases
|
Opdivo (nivolumab) • paclitaxel • Cyramza (ramucirumab) • ABP 206 (nivolumab biosimilar)
7ms
New P2 trial • Mismatch repair
|
Opdivo (nivolumab) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar)
7ms
New P1 trial • Combination therapy • Metastases
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar) • Cdactin-O (CBM588)
7ms
Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma (clinicaltrials.gov)
P1, N=32, Suspended, National Cancer Institute (NCI) | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
Trial completion date • Trial primary completion date
|
Opdivo (nivolumab) • Rituxan (rituximab) • lenalidomide • methotrexate • ABP 206 (nivolumab biosimilar) • Mabtas (rituximab biosimilar) • methotrexate IV
7ms
Trial completion date • Trial primary completion date • Metastases
|
BRAF mutation • BRAF V600
|
THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
|
Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)