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DRUG CLASS:

CTLA4 inhibitor

2d
Neoadjuvant cadonilimab plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma: A multicenter, phase 2 study. (PubMed, Med)
Neoadjuvant cadonilimab plus FLOT chemotherapy treatment exhibits promising efficacy with manageable toxicities in locally advanced G/GEJ adenocarcinoma, providing preliminary evidence for further investigation.
P2 data • Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab)
3d
Randomized Phase II Study of Durvalumab with or without Tremelimumab in Patients with Metastatic Castration Resistant Prostate Cancer. (PubMed, Clin Cancer Res)
D+T is active in mCRPC but patient selection remains a challenge. Further studies to develop predictive biomarkers are warranted.
P2 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8)
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TMB-H • PD-L1 overexpression
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Imfinzi (durvalumab) • Xtandi (enzalutamide capsule) • Imjudo (tremelimumab) • abiraterone acetate
3d
Comparative efficacy of combined CTLA-4 and PD-1 blockade vs. PD-1 monotherapy in metastatic melanoma: a real-world study. (PubMed, BJC Rep)
Our real-world data indicate that combined CTLA-4 and PD-1 blockade is most beneficial for patients with multi-organ metastasis, while those with oligo-organ metastasis fare better with PD-1 monotherapy. The underlying reasons for these observations-whether they are due to differences in the characteristics of multi- and oligo-metastatic melanomas or the risk-benefit profile of the therapies-remain to be elucidated. These findings underscore the need for a nuanced approach to treatment regimens for stage IV melanoma patients.
Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world • Metastases
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BRAF (B-raf proto-oncogene) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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BRAF mutation
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
3d
APiTOXMM: Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management (clinicaltrials.gov)
P=N/A, N=160, Recruiting, University Hospital, Montpellier | Not yet recruiting --> Recruiting
Enrollment open
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
3d
Nivolumab with or Without Ipilimumab in Treating Patients with Recurrent or High Grade Gynecologic Cancer with Metastatic Peritoneal Carcinomatosis (clinicaltrials.gov)
P1, N=26, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Nov 2024 | Trial primary completion date: Apr 2025 --> Nov 2024
Trial completion • Trial completion date • Trial primary completion date • Metastases
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Opdivo (nivolumab) • Yervoy (ipilimumab)
4d
MARIANE: Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma (clinicaltrials.gov)
P1/2, N=96, Recruiting, The Netherlands Cancer Institute | Not yet recruiting --> Recruiting | Trial completion date: May 2026 --> Mar 2034 | Trial primary completion date: Feb 2026 --> Jul 2029
Enrollment open • Trial completion date • Trial primary completion date
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Opdivo (nivolumab) • Yervoy (ipilimumab)
5d
Enrollment open
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Avastin (bevacizumab) • Tyvyt (sintilimab) • Ariely (adebrelimab) • SHR-8068
5d
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
P2, N=90, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Phase classification: P1 --> P2
Phase classification
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PD-L1 (Programmed death ligand 1)
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Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
5d
New P3 trial
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Qibeian (iparomlimab/tuvonralimab)
6d
ESR-22-21719: Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
P2, N=0, Withdrawn, Georgetown University | N=28 --> 0 | Recruiting --> Withdrawn
Enrollment change • Trial withdrawal
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cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
6d
Trial completion
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Opdivo (nivolumab) • Yervoy (ipilimumab) • plinabulin (BPI 2358)
6d
Enrollment open
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SHR-A2102 • Ariely (adebrelimab) • SHR-8068
6d
New P1/2 trial
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Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
6d
Durvalumab Plus Tremelimumab for the Treatment of Patients with Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial (clinicaltrials.gov)
P2, N=79, Terminated, Grupo Espanol de Tumores Neuroendocrinos | Trial completion date: Dec 2025 --> Nov 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Nov 2024; In compliance with current legislation applicable to Clinical Trials, following the instructions of the Spanish Agency for Medicines and Health Products.
Trial completion date • Trial termination • Trial primary completion date • Metastases
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Imfinzi (durvalumab) • Imjudo (tremelimumab)
8d
Study on Cadonilimab Plus mFOLFIRINOX in patients with locally advanced pancreatic cancer (ChiCTR2400088986)
P=N/A, N=30, Not yet recruiting, Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University); Jiangsu Province Hospital (The First Affiliated Hospital wi
New trial • Metastases
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CA 19-9 (Cancer antigen 19-9)
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oxaliplatin • irinotecan • Kaitanni (cadonilimab)
8d
AK104 in combination with AK112 in an exploratory, multi-cohort stage II treatment of recurrent ovarian cancer study (ChiCTR2400090899)
P2, N=172, Not yet recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
New P2 trial • Combination therapy • IO biomarker
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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Kaitanni (cadonilimab) • Yidafan (ivonescimab)
8d
New P2 trial • Metastases
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cisplatin • gemcitabine • Kaitanni (cadonilimab)
8d
New P2 trial • Metastases
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KRAS (KRAS proto-oncogene GTPase)
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KRAS wild-type • RAS wild-type
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Fruzaqla (fruquintinib) • Kaitanni (cadonilimab)
10d
Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease (clinicaltrials.gov)
P2, N=222, Completed, ETOP IBCSG Partners Foundation | Active, not recruiting --> Completed
Trial completion
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Opdivo (nivolumab) • Yervoy (ipilimumab)
10d
New P2 trial • Metastases
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Focus V (anlotinib) • Kaitanni (cadonilimab)
10d
Enrollment open • Combination therapy • Checkpoint inhibition • Metastases
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Opdivo (nivolumab) • Yervoy (ipilimumab) • RP2
11d
Esophagomediastinal fistula during durvalumab plus tremelimumab with chemotherapy in angiotensin-converting enzyme 2-positive non-small cell lung cancer: a case report. (PubMed, Transl Lung Cancer Res)
The treatment regimen comprised durvalumab, tremelimumab, carboplatin, and nab-paclitaxel. Clinicians should be aware that COVID-19 might be associated with the development of severe irAEs and unexpectedly enhanced antitumor effects. The findings also suggest new fields of study regarding the interaction between viral infection and tumor immune response, which may inform future therapeutic approaches.
Journal • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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EGFR mutation
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carboplatin • Imfinzi (durvalumab) • albumin-bound paclitaxel • Imjudo (tremelimumab)
11d
Trial suspension • Metastases
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Opdivo (nivolumab) • Yervoy (ipilimumab)
12d
Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. (PubMed, J Clin Oncol)
In this large, pooled nonrandomized retrospective analysis, we observed that NIVO + IPI provides longer OS than NIVO in patients with ICI treatment-naïve advanced melanoma and identifies clinical factors that appear to be associated with survival for each treatment, which may assist with treatment decision making.
Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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PD-L1 expression • BRAF mutation • BRAF wild-type • PD-L1-L
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Opdivo (nivolumab) • Yervoy (ipilimumab)
12d
Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC (clinicaltrials.gov)
P1, N=24, Active, not recruiting, University of Utah | Trial primary completion date: Apr 2025 --> Jan 2024
Trial primary completion date • Combination therapy
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EGFR mutation
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Tagrisso (osimertinib) • Yervoy (ipilimumab)
12d
Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment (clinicaltrials.gov)
P1, N=18, Terminated, The Netherlands Cancer Institute | N=34 --> 18 | Trial completion date: Jan 2021 --> Nov 2024 | Unknown status --> Terminated | Trial primary completion date: Jan 2021 --> Nov 2024; Based on initially defined safety rules not continued with expansion phase of study (too much toxicity with neo-adjuvant immunotherapy)
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
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cisplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
13d
Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab (clinicaltrials.gov)
P2, N=67, Active, not recruiting, Abramson Cancer Center at Penn Medicine | Recruiting --> Active, not recruiting
Enrollment closed
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Opdivo (nivolumab) • Yervoy (ipilimumab)
13d
Trial initiation date • Combination therapy • Checkpoint inhibition • IO biomarker
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PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
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PD-L1 expression • BRCA2 mutation • BRCA1 mutation • BRCA mutation
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PD-L1 IHC 22C3 pharmDx
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Keytruda (pembrolizumab) • Yervoy (ipilimumab)
13d
Hepatic Ablation of Melanoma Metastases to Enhance Immunotherapy Response, a Phase I Clinical Trial (HAMMER I) (clinicaltrials.gov)
P1, N=2, Completed, University of Michigan Rogel Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jun 2025 --> Jul 2024
Trial completion • Trial completion date
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IFNA1 (Interferon Alpha 1)
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Opdivo (nivolumab) • Yervoy (ipilimumab)
14d
NEXIS: Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma (clinicaltrials.gov)
P1/2, N=22, Terminated, University of Maryland, Baltimore | Trial completion date: Jun 2037 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2032 --> Jun 2024; Limited Accrual
Trial completion date • Trial termination • Trial primary completion date
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Imfinzi (durvalumab) • Imjudo (tremelimumab)
14d
CHAMP: A Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer (clinicaltrials.gov)
P2, N=43, Recruiting, Andrew J. Armstrong, MD | Trial completion date: Jun 2027 --> Jun 2028 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
|
TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • SYP (Synaptophysin)
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LDH elevation
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Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • cabazitaxel
17d
AK104-214: AK104 in Neoadjuvant Treatment of Cervical Cancer (clinicaltrials.gov)
P2, N=14, Completed, Akeso | Not yet recruiting --> Completed | N=30 --> 14 | Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Mar 2023 --> Sep 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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Kaitanni (cadonilimab)
17d
New P2 trial
|
izalontamab (SI-B001) • danvilostomig (SI-B003)
17d
MT-8421-001: Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types (clinicaltrials.gov)
P1, N=15, Terminated, Molecular Templates, Inc. | Active, not recruiting --> Terminated; Sponsor Termination
Trial termination
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PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • PD-1 (Programmed cell death 1)
|
MSI-H/dMMR
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Opdivo (nivolumab) • MT-8421
18d
NeoRelapse: Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma (clinicaltrials.gov)
P2, N=25, Recruiting, University of Utah | Not yet recruiting --> Recruiting | Initiation date: Aug 2024 --> Nov 2024
Enrollment open • Trial initiation date
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Opdivo (nivolumab) • Yervoy (ipilimumab)
18d
Enrollment change • Combination therapy • Metastases
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Neo Vax (NEO-PV-01)
18d
The first case of primary malignant melanoma of the esophagus to achieve pathologic complete response after preoperative ipilimumab + nivolumab followed by resection. (PubMed, Clin J Gastroenterol)
Studies have reported the efficacy of programmed cell death-1 inhibitors (e.g., nivolumab, pembrolizumab) and anti-cytotoxic T-lymphocyte-associated antigen 4 agents (e.g., ipilimumab) in treating malignant melanoma. Histopathological examination revealed no tumors or lymph node metastases, confirming a pathologic complete response. Given the rarity and poor prognosis of primary malignant melanoma of the esophagus, this case provides valuable insights for treatment strategies.
Journal
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CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
18d
WNT/β-catenin Signaling and CD8+ Tumor-infiltrating Lymphocytes in Tremelimumab Plus Durvalumab for Advanced Hepatocellular Carcinoma. (PubMed, In Vivo)
Although the present study involved a small number of patients, the findings suggest that the efficacy of tremelimumab plus durvalumab may be affected by WNT/β-catenin signaling and CD8+ TIL infiltration.
Journal • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CD8 (cluster of differentiation 8)
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Imfinzi (durvalumab) • Imjudo (tremelimumab)
19d
A Complete Response to Combined Immunotherapy in a Patient with an ATM plus SF3B1 Mutation and a Moderate Tumor Mutational Burden with a High-Grade Treatment-Emergent Neuroendocrine Prostate Cancer: Case Report and Review of the Literature. (PubMed, Case Rep Oncol)
We describe an impressive response to IO combination immunotherapy with ipilimumab plus nivolumab (Ipi/nivo) in a patient with T-NEPC who had failed standard treatment approaches. The results of the next-generation sequencing DNA analysis demonstrated the presence of intermediary tumor burden, an ATM mutation and a rare SF3B1 (G742D) mutation, and served as rational for IO therapy in this patient. This case highlights the genetic profile of tumor with a rare combination of ATM and SF3B1 mutations that could be further explored as biomarkers for IO therapy in T-NEPC and other tumor types.
Review • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • ATM (ATM serine/threonine kinase) • SF3B1 (Splicing Factor 3b Subunit 1)
|
ATM mutation • SF3B1 mutation
|
Opdivo (nivolumab) • Yervoy (ipilimumab)
19d
New P3 trial • Metastases
|
cisplatin • capecitabine • albumin-bound paclitaxel • Kaitanni (cadonilimab)
19d
NeoVax Plus Ipilimumab in Renal Cell Carcinoma (clinicaltrials.gov)
P1, N=19, Active, not recruiting, Patrick Ott, MD, PhD | Trial completion date: Sep 2026 --> May 2030
Trial completion date
|
Yervoy (ipilimumab) • Neo Vax (NEO-PV-01)
20d
CA209-9DJ: A Study to Test the Safety of Immunotherapy With Nivolumab Alone or With Ipilimumab Before Surgery for Bladder Cancer Patients Who Are Not Suitable for Chemotherapy (clinicaltrials.gov)
P2, N=45, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2025 --> Jan 2026
Trial completion date • Trial primary completion date • Combination therapy • Surgery
|
Opdivo (nivolumab) • Yervoy (ipilimumab)