Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000139-28 | EudraCT Number | ||
| KEYNOTE-764 | Other Identifier | Merck Sharp & Dohme Corp |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this study is to determine if IO102 combined with pembrolizumab with or without chemotherapy is safe tolerable and effective in the treatment of Non-small Cell Lung Carcinoma (NSCLC).
The hypothesis is that IO102 will improve the objective response rate (ORR) in patients with metastatic NSCLC.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 | Experimental | Drug: IO102 100µg administered subcutaneously (SC) on Day 1 of each 3 week cycle PLUS Drug: pembrolizumab (Keytruda) 200 mg intravenous (IV) infusion on Day 1 of each 3 week cycle |
|
| Cohort A2 | Active Comparator | Drug: pembrolizumab (Keytruda) 200 mg IV infusion on Day 1 of each 3 week cycle |
|
| Cohort B1 | Experimental | Drug: IO102 100µg SC on Day 1 of each 3 week cycle PLUS Drug: pembrolizumab (Keytruda) 200 mg IV on Day 1 of each 3 week cycle PLUS Drug: carboplatin (Carboplatin Kabi) at a target AUC of 5 mg/mL IV infusion on Day 1 of each 3 week cycle for a max of 4 administrations PLUS Drug: pemetrexed (Pemetrexed Alvogen) at 500 mg/m2 IV infusion on Day 1 of each 3 week cycle |
|
| Cohort B2 | Active Comparator | Drug: pembrolizumab (Keytruda) 200 mg IV on Day 1 of each 3 week cycle PLUS Drug: carboplatin (Carboplatin Kabi) at a target AUC of 5 mg/mL IV infusion on Day 1 of each 3 week cycle for a max of 4 administrations PLUS Drug: pemetrexed (Pemetrexed Alvogen) at 500 mg/m2 IV infusion on Day 1 of each 3 week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IO102 | Biological | test immunotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 (safety run-in) | Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 | One cycle i.e. 3 weeks |
| Phase 2 (efficacy) | Objective Response Rate (ORR) evaluated by RECIST 1.1 and defined as the rate of complete response (CR) + partial response (PR) | From date of randomization until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, assessed for up to 35 cycles (2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | by baseline PD-L1 expression | From date of randomization until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, assessed for up to 35 cycles (2 years) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Spicer, MD Prof | Guy's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik Heidelberg gGmbH | Heidelberg | Community of Heidelberg | 69126 | Germany | ||
| PIUS Hospital Oldenburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27745820 | Background | Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10. | |
| 27718847 |
Not provided
Not provided
All unpublished information relating to this trial and/or to the trial treatments is considered confidential by the Sponsor and shall remain the sole property of the Sponsor.
The Investigator must accept that the Sponsor may use the information from this clinical trial in connection with the development of the IO102, and therefore, may disclose it as required to other Investigators, to government licensing authorities, to regulatory agencies of other governments, stock exchange market, and commercial partners.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| pembrolizumab (Keytruda) |
| Biological |
anti-PD-1 immunotherapy |
|
| Carboplatin (Carboplatin Kabi) | Drug | chemotherapy |
|
| Pemetrexed (Pemetrexed Alvogen) | Drug | chemotherapy |
|
| Oldenburg |
| 26121 |
| Germany |
| Stichting Het Nederlands Kanker Instituut | Amsterdam | Community of Amsterdam | Netherlands |
| Servicio de Oncología-El médico del Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Insituto Oncologico Dr Rosell. Hospital Universitario Quiron Dexeus | Barcelona | Catalonia | 08028 | Spain |
| Hospital Universitario de Vall d'Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Universitari de Girona Doctor Josep Trueta | Girona | Catalonia | 17007 | Spain |
| Hospital Clinico Universitario de València | Valencia | Horta de València | 46010 | Spain |
| Hospital Universitario 12 Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | Madrid | 28050 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | 28134 | Spain |
| Hospital Puerta del Hierro Majadahonda | Madrid | Madrid | Spain |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Background |
| Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8. |
| 24218513 | Background | Iversen TZ, Engell-Noerregaard L, Ellebaek E, Andersen R, Larsen SK, Bjoern J, Zeyher C, Gouttefangeas C, Thomsen BM, Holm B, Thor Straten P, Mellemgaard A, Andersen MH, Svane IM. Long-lasting disease stabilization in the absence of toxicity in metastatic lung cancer patients vaccinated with an epitope derived from indoleamine 2,3 dioxygenase. Clin Cancer Res. 2014 Jan 1;20(1):221-32. doi: 10.1158/1078-0432.CCR-13-1560. Epub 2013 Nov 11. |
| 26063792 | Background | Andersen MH. Immune Regulation by Self-Recognition: Novel Possibilities for Anticancer Immunotherapy. J Natl Cancer Inst. 2015 Jun 10;107(9):djv154. doi: 10.1093/jnci/djv154. Print 2015 Sep. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2024 | May 20, 2024 | 20 | ||
| Feb 11, 2026 | Mar 3, 2026 | 21 |
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided