^
4d
New P3 trial • Metastases
|
Keytruda (pembrolizumab) • Yervoy (ipilimumab) • carboplatin • temozolomide • albumin-bound paclitaxel • cyclophosphamide • dacarbazine • Opdualag (nivolumab/relatlimab-rmbw) • Amtagvi (lifileucel) • relatlimab (BMS-986016) • IMA203
14d
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (clinicaltrials.gov)
P3, N=680, Recruiting, Immunocore Ltd | Trial primary completion date: Dec 2026 --> Oct 2027
Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
BRAF mutation • BRAF V600 • HLA-A*02
|
Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
17d
STELLA: Administration of Donor MultiTAA-Specific T Cells for ALL (clinicaltrials.gov)
P1, N=40, Completed, Baylor College of Medicine | Active, not recruiting --> Completed
Trial completion
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • MME (Membrane Metalloendopeptidase)
|
MultiTAA T cell therapy
19d
Immunohistochemical Expression and Significance of Preferentially Expressed Antigen in Melanoma (PRAME) in Gynecological Tumors: A Single-institution Retrospective Analysis. (PubMed, Anticancer Res)
PRAME over-expression in gynecological tumors supports the notion that this marker should not be regarded as specific to MM alone. EC exhibited higher PRAME expression than CC and OC, and low-grade EEC displayed higher PRAME immunoreactivity than other EC types. Our findings suggest that PRAME immunostaining can be useful to distinguish EEC from ovarian endometrioid carcinoma and endocervical adenocarcinoma. PRAME over-expression can also help differentiate non-aggressive EC from aggressive EC.
Retrospective data • Journal
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PRAME (Preferentially Expressed Antigen In Melanoma)
20d
Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study. (PubMed, Lancet Oncol)
In patients with heavily pretreated T-cell lymphoma, CTX130 showed manageable safety and a promising objective response rate. This study shows that allogeneic, readily available CAR T cells can be safely given to patients with relapsed or refractory T-cell lymphoma. A next-generation CAR T-cell therapy containing additional potency gene edits (CTX131) is in clinical development.
P1 data • Journal • CAR T-Cell Therapy
|
CD70 (CD70 Molecule)
|
cyclophosphamide • fludarabine IV • CTX130 • CTX131
2ms
Significance of the preferentially expressed antigen in melanoma in discriminating the conjunctival malignant melanoma and pigmented nevus (PubMed, Zhonghua Yan Ke Za Zhi)
The PRAME has significance in discriminating the conjunctival malignant melanoma and pigmented nevus. It is a useful biomarker in the diagnosis of conjunctival malignant melanoma.
Journal
|
PRAME (Preferentially Expressed Antigen In Melanoma)
|
PRAME expression
2ms
New P1 trial
|
cyclophosphamide • fludarabine IV
2ms
IMC-F106C-101: Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors (clinicaltrials.gov)
P1/2, N=727, Recruiting, Immunocore Ltd | Trial primary completion date: Jun 2026 --> Feb 2026
Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)
|
HLA-A*02
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Kimmtrak (tebentafusp-tebn) • brenetafusp (IMC-F106C)
3ms
Enrollment open
|
cyclophosphamide • decitabine • fludarabine IV
3ms
BRCA1-associated-protein-1 inactivated melanocytic tumours: characterisation of the clinicopathological spectrum and immunohistochemical expression pattern of preferentially expressed antigen in melanoma. (PubMed, Histopathology)
BIMT are more common in a sporadic setting and behave indolently, despite worrying cytological atypia. PRAME immunohistochemistry is a reassuring tool in distinguishing BIMT from melanoma.
Journal • BRCA Biomarker
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BRCA1 (Breast cancer 1, early onset) • BAP1 (BRCA1 Associated Protein 1) • PRAME (Preferentially Expressed Antigen In Melanoma)
4ms
Enrollment change
|
Opdivo (nivolumab) • IMA203 • IMA203CD8
4ms
COMPREHENSIVE MOLECULAR PROFILING OF UVEAL MELANOMA EVALUATED WITH GENE EXPRESSION PROFILING, PREFERENTIALLY EXPRESSED ANTIGEN IN MELANOMA EXPRESSION, AND NEXT-GENERATION SEQUENCING. (PubMed, Retina)
GEP, NGS, and PRAME expression analysis help determine different levels of metastatic risk in UM. Although other prognostic tests exist, the following study reports on the use of NGS for metastatic prognostication in UM. However, limitations of NGS exist, especially with small lesions that are technically difficult to biopsy.
Retrospective data • Journal • Next-generation sequencing • BRCA Biomarker
|
SF3B1 (Splicing Factor 3b Subunit 1) • BAP1 (BRCA1 Associated Protein 1) • BRCA (Breast cancer early onset) • PRAME (Preferentially Expressed Antigen In Melanoma)
4ms
New P1 trial • Metastases
5ms
Enrollment closed
|
cyclophosphamide • decitabine • fludarabine IV
5ms
Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM) (clinicaltrials.gov)
P1, N=44, Recruiting, Baylor College of Medicine | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Apr 2024 --> Apr 2025
Trial completion date • Trial primary completion date
|
KIT (KIT proto-oncogene, receptor tyrosine kinase) • WT1 (WT1 Transcription Factor) • CD33 (CD33 Molecule) • ANPEP (Alanyl Aminopeptidase, Membrane)
|
MultiTAA T cell therapy
5ms
TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (clinicaltrials.gov)
P2, N=12, Active, not recruiting, Baylor College of Medicine | Trial completion date: May 2024 --> May 2025
Trial completion date
|
MultiTAA T cell therapy
6ms
Enrollment open • Trial initiation date
|
cyclophosphamide • decitabine • fludarabine IV
7ms
Enrollment change
8ms
New P1/2 trial
|
cyclophosphamide • decitabine • fludarabine IV
9ms
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors (clinicaltrials.gov)
P1/2, N=727, Recruiting, Immunocore Ltd | N=170 --> 727 | Trial completion date: Feb 2026 --> Jun 2026 | Trial primary completion date: Feb 2024 --> Jun 2026
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
|
HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)
|
HLA-A*02
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Kimmtrak (tebentafusp-tebn) • brenetafusp (IMC-F106C)
9ms
Performance of preferentially expressed antigen in melanoma (PRAME) immunohistochemistry for metastatic melanoma in cytology specimens. (PubMed, Diagn Cytopathol)
PRAME is a useful marker for the diagnosis of melanoma in cytology material, but it is less sensitive than SOX10. PRAME is also expressed in other nonmelanocytic tumors which limits its specificity.
Journal • IO biomarker • Metastases • Cytology
|
SOX10 (SRY-Box 10) • PRAME (Preferentially Expressed Antigen In Melanoma) • MLANA (Melan-A)
|
PRAME expression
9ms
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM) (clinicaltrials.gov)
P1, N=45, Active, not recruiting, CRISPR Therapeutics AG | Recruiting --> Active, not recruiting
Enrollment closed
|
CTX130
10ms
Enrollment open • Metastases
|
BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
BRAF mutation • BRAF V600 • HLA-A*02
|
Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
10ms
A Comparison of Preferentially Expressed Antigen in Melanoma Immunohistochemistry and Diagnostic Gene Expression-Profiling Assay in Challenging Melanocytic Proliferations. (PubMed, Am J Dermatopathol)
GEP agreed with the final diagnosis in 88% of cases with a sensitivity of 65%, 97% specificity, and positively predicted melanoma in 91.7% of cases. Because the results of this study align with past publications evaluating the performance metrics of PRAME IHC, showing it to be as sensitive as and more cost effective than all other ancillary molecular tests, we propose the use of PRAME IHC as the optimal first-line diagnostic tool for ambiguous melanocytic proliferations.
Journal
|
PRAME (Preferentially Expressed Antigen In Melanoma)
11ms
Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT (clinicaltrials.gov)
P1/2, N=22, Active, not recruiting, NexImmune Inc. | Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Mar 2025 | Trial primary completion date: Oct 2022 --> Oct 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
|
cyclophosphamide • NEXI-001
1year
Expression of Preferentially Expressed Antigen in Melanoma, a Cancer/Testis Antigen, in Carcinoma In Situ of the Urinary Tract. (PubMed, Diagnostics (Basel))
Therefore, PRAME expression may serve as a useful marker for CIS of the urinary tract. Furthermore, PRAME may be a candidate for the novel therapeutic target for standard treatment-refractory CIS patients.
Journal
|
TP53 (Tumor protein P53) • PRAME (Preferentially Expressed Antigen In Melanoma)
|
TP53 expression • PRAME expression
1year
PReferentially Expressed Antigen in MElanoma Expression in Uterine and Ovarian Carcinosarcomas. (PubMed, Int J Gynecol Pathol)
Our results further support PRAME overexpression in gynecologic cancers, including CS with similar expression levels in epithelial and mesenchymal components. PRAME might have a role in epithelial-mesenchymal transition in this group of cancers.
Journal • IO biomarker
|
PRAME (Preferentially Expressed Antigen In Melanoma)
|
PRAME expression
1year
New P3 trial • Metastases
|
BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD163 (CD163 Molecule)
|
BRAF mutation • BRAF V600 • HLA-A*02
|
Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
1year
Safety & Activity of Controllable PRAME-TCR Therapy in Previously Treated AML/MDS or Metastatic Uveal Melanoma (clinicaltrials.gov)
P1/2, N=4, Terminated, Bellicum Pharmaceuticals | N=28 --> 4 | Unknown status --> Terminated; company decision
Enrollment change • Trial termination • Metastases
|
PRAME (Preferentially Expressed Antigen In Melanoma)
|
PRAME expression
|
BPX-701 • rimiducid (AP1903)
over1year
Clinical • Metastases
|
PRAME (Preferentially Expressed Antigen In Melanoma)
|
IMA203
over1year
Clinical • Metastases
|
PRAME (Preferentially Expressed Antigen In Melanoma)
|
IMA203
over1year
Metastases
|
PD-1 (Programmed cell death 1) • PRAME (Preferentially Expressed Antigen In Melanoma)
|
IMA203
over1year
WT1 and PRAME RNA-loaded dendritic cell vaccine as maintenance therapy in de novo AML after intensive induction chemotherapy. (PubMed, Leukemia)
Oral azacytidine may be used as maintenance treatment in AML in first remission, but can be associated with substantial side effects, and less toxic strategies should be explored. OS at five years was 75% (95% CI: 50-89), with 70% of patients ≥60 years of age being long-term survivors. Maintenance therapy with this DC vaccine was well tolerated in AML patients in CR1 and was accompanied by encouraging 5-year long-term survival.
Journal
|
PRAME (Preferentially Expressed Antigen In Melanoma)
|
azacitidine • CVT-DC-01 • DC vaccine for prostate cancer
over1year
Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM) (clinicaltrials.gov)
P1, N=44, Recruiting, Baylor College of Medicine | Trial primary completion date: Apr 2023 --> Apr 2024
Trial primary completion date
|
KIT (KIT proto-oncogene, receptor tyrosine kinase) • WT1 (WT1 Transcription Factor) • CD33 (CD33 Molecule) • ANPEP (Alanyl Aminopeptidase, Membrane)
|
MultiTAA T cell therapy
over1year
Study of Mana 312 (Multi Tumor-Associated Antigen T Cells) in Adults With AML/MDS After HSCT (clinicaltrials.gov)
P1, N=11, Terminated, Mana Therapeutics | N=27 --> 11 | Active, not recruiting --> Terminated; Product manufacturing
Enrollment change • Trial termination
|
MANA-312
over1year
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC) (clinicaltrials.gov)
P1, N=107, Active, not recruiting, CRISPR Therapeutics AG | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
CTX130
over1year
An analysis of a first-in-human study of NEXI-001 donor-derived antigen-specific CD8+ T-cell treatment of relapsed AML after allogeneic hematopoietic cell transplantation (HCT). (ASCO 2023)
Early results indicate that the antigen-specific NEXI-001 T cells have the potential to enhance GvL effects and is tolerated with easily manageable side effects. Greater clinical activity has been observed with increased doses of the NEXI-001 T cells. The trial remains ongoing, and the data support an Expansion Cohort of the study that will allow for a more complete assessment of clinical activity.
P1 data
|
CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule) • PRAME (Preferentially Expressed Antigen In Melanoma) • CCNA1 (Cyclin A1)
|
NEXI-001
over1year
Prognostic Value of BAP1 and Preferentially Expressed Antigen in Melanoma (PRAME) Immunohistochemistry in Uveal Melanomas. (PubMed, Mod Pathol)
Among tumors with retained BAP1 staining, PRAME positivity was associated with shorter MFS and DSS (P = .001 and P = .021, respectively). In summary, a combination of BAP1 and PRAME IHC can be used for risk stratification of UMs.
Retrospective data • Journal
|
BAP1 (BRCA1 Associated Protein 1) • PRAME (Preferentially Expressed Antigen In Melanoma)
|
BAP1 mutation
over1year
PReferentially Expressed Antigen in MElanoma (PRAME): preliminary communication on a translational tool able to early detect Oral Malignant Melanoma (OMM). (PubMed, J Cancer)
This means a better differential diagnosis, a reliable early diagnosis and a proper clinical/surgical management of the oncological lesions. In conclusion, PRAME can be a valid qualitative marker for differential diagnosis, not only in cutaneous melanomas, but also in malignant melanoma of the entire head and neck area.
Journal
|
PRAME (Preferentially Expressed Antigen In Melanoma)
|
PRAME expression
almost2years
HDAC5-mediated PRAME regulates the proliferation, migration, invasion, and EMT of laryngeal squamous cell carcinoma via the PI3K/AKT/mTOR signaling pathway. (PubMed, Open Med (Wars))
Moreover, PRAME played the role at least partially by activating PI3K/AKT/mTOR pathways. The above findings elucidate that PRAME may be a valuable oncogene target, contributing to the diagnosis and therapy of LSCC.
Journal
|
PRAME (Preferentially Expressed Antigen In Melanoma) • HDAC5 (Histone Deacetylase 5)
|
PRAME expression