7 trials tracked · 6 active · last refreshed 2026-08-10
Tedopi (also listed under its code name OSE2101, and its component OSE-279) is OSE Immunotherapeutics' fixed peptide vaccine, presenting ten tumor-associated peptides to trigger a T-cell response — mainly developed for non-small cell lung cancer in patients who've already progressed after checkpoint-inhibitor treatment, a setting with few good options. Its most advanced active trial is Phase III, testing it head-to-head in that post-checkpoint-inhibitor population.
Several other active trials pair it with a checkpoint inhibitor or chemotherapy rather than using it alone (with cemiplimab, with docetaxel or nivolumab, with FOLFIRI after pancreatic cancer chemotherapy), and one dose-finding trial is testing OSE-279, a related but distinct molecule from the same company, across a broader set of advanced solid tumors.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | NCT07264673 | A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study. | Phase II | Recruiting | 2025-04-17 |
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy. Enrollment 160 (estimated) Sites 1 across 1 country Countries Italy Sponsor Fondazione Ricerca Traslazionale Primary outcome: ctDNA clearance rate | |||||
| ▸ | NCT06472245 | Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor | Phase III | Recruiting | 2024-12-03 |
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1). Enrollment 363 (estimated) Sites 207 across 14 countries Countries Belgium, Canada, France, Germany, Greece +9 more Sponsor OSE Immunotherapeutics Primary outcome: OS defined as time from randomization to death | |||||
| ▸ | NCT05751798 | Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas | Phase I, Phase II | Recruiting | 2022-12-20 |
This is a phase 1/2, multicenter, dose-finding and dose expansion study of OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas. Enrollment 41 (estimated) Sites 11 across 3 countries Countries Belgium, France, Spain Sponsor OSE Immunotherapeutics Primary outcome: Part A: Occurrence of dose limiting toxicity (DLT). Part B: Safety and tolerability of the combination OSE-279/OSE2101. Part C: Overall response rate (ORR) of the combination OSE-279/OSE2101 | |||||
| ▸ | NCT04884282 | Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) | Phase II | Active, not recruiting | 2021-10-12 |
This is a phase II, non-comparative, randomized study assessing combination of Tedopi with docetaxel or with nivolumab in NSCLC patients failing after first- line chemoimmunotherapy. In this non-comparative study, the standard arm (arm C) will serve as a calibration arm. All NSCLC patients candidate for second- line therapy are considered eligible for the study if they are HLA-A2+ and if they progressed after at least 4 cycles of previous first-line chemo-immunotherapy. After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will be treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C- standard arm). Docetaxel therapy will be given until disease progression, unacceptable toxicity or patient refusal, and up to maximum 6 cycles. Tedopi or nivolumab will be given until disease progression, unacceptable toxicity or patient refusal. Enrollment 105 (estimated) Sites 23 across 3 countries Countries France, Italy, Spain Sponsor Fondazione Ricerca Traslazionale Primary outcome: 1-year Survival Rate | |||||
| ▸ | NCT04713514 | OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC | Phase II | Active, not recruiting | 2021-08-05 |
The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible). Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose). Enrollment 180 (estimated) Sites 40 across 3 countries Countries Belgium, France, Germany Sponsor ARCAGY/ GINECO GROUP Primary outcome: Progression free survival (PFS) | |||||
| ▸ | NCT03806309 | OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC | Phase II | Active, not recruiting | 2021-04-10 |
TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after induction therapy with FOLFIRINOX. Enrollment 106 (estimated) Sites 28 across 1 country Countries France Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group Primary outcome: Overall Survival (OS) | |||||
| ▸ | NCT02654587 | OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure | Phase III | Terminated | 2016-02-12 |
The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint inhibitor given in first or second-line treatment. The main questions were to compare the survival, the tolerance to treatment and the quality of life of patients between the two arms of treatment (OSE2101 versus standard chemotherapy) Enrollment 219 (actual) Sites 78 across 10 countries Countries Czechia, France, Germany, Hungary, Israel +5 more Sponsor OSE Immunotherapeutics Primary outcome: Overall Survival (OS) | |||||
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