Therapy Detail
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| Therapy Name | IO102-IO103 + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| IO102-IO103 | PD-L1/IDO Peptide Vaccine|IO103/IO102 Peptide Vaccine | IO102-IO103 is a peptide vaccine comprised of long peptides derived from IDO and PD-L1, which may result in activation of IDO and PD-L1 specific T lymphocytes, potentially leading to increased antitumor immune response (Annals of Oncology 31 (2020): S1176). | ||
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 | Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CD274 positive | head and neck squamous cell carcinoma | predicted - sensitive | IO102-IO103 + Pembrolizumab | Case Reports/Case Series | Actionable | In a Phase II trial, treatment with the combination of IO102-IO103 and Keytruda (pembrolizumab) demonstrated safety and resulted in a partial response in 50% (2/4, 1 confirmed partial response) in patients with squamous cell carcinoma of the head and neck with CD274 (PD-L1) expression (combined positive scores >/=20) (Ann Oncol (2023) 34 (suppl_2): S630; NCT05077709). | detail... |
| CD274 over exp | lung non-small cell carcinoma | predicted - sensitive | IO102-IO103 + Pembrolizumab | Phase II | Actionable | In a Phase II trial, treatment with the combination of IO102-IO103 and Keytruda (pembrolizumab) demonstrated safety and resulted in a partial response in 53.3% (8/15, 4 confirmed partial responses) and 5 with stable disease in non-small cell lung cancer patients with CD274 (PD-L1) expression (tumor proportion score >/=50%) (Ann Oncol (2023) 34 (suppl_2): S630; NCT05077709). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05977907 | Phase II | IO102-IO103 + Pembrolizumab | Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN). (KIEO) | Recruiting | USA | 0 |
| NCT05843448 | Phase I | IO102-IO103 + Pembrolizumab | IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer | Recruiting | USA | 0 |
| NCT05077709 | Phase II | IO102-IO103 + Pembrolizumab | IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC | Active, not recruiting | USA | GBR | ESP | 0 |
| NCT05155254 | Phase III | IO102-IO103 + Pembrolizumab Pembrolizumab | IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) | Active, not recruiting | USA | TUR | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | BEL | AUS | 1 |
| NCT05280314 | Phase II | IO102-IO103 + Pembrolizumab | Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab in Patients With Resectable Tumors | Recruiting | USA | FRA | ESP | DNK | DEU | AUS | 0 |
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