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GM-CSF · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sunitinib | ACTIVE_COMPARATOR | Sunitib as Standard therapy per Label. |
| IMA901 plus GM-CSF added to sunitinib after single dose of cy | EXPERIMENTAL | After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant after a single dose of cyclophosphamide will be applied for a period of 4 months while continuing treatment with sunitinib |
| Name | Type | Description |
|---|---|---|
| Sunitinib | DRUG | As per label. |
| GM-CSF | BIOLOGICAL | Intradermal injection of GM-CSF as adjuvant. |
| Cyclophosphamide | DRUG | One single low-dose i.v. infusion prior to the first vaccination |
| IMA901 | DRUG | Intradermal vaccinations with IMA901 vaccine. |
Inclusion Criteria: 1. Aged at least 18 years. 2. HLA type: HLA-A\*02-positive 3. Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required. 4. Measurable and/or non-measurable tumor lesions as...
GM-CSF is an investigational monoclonal antibody being studied for the treatment of metastatic renal cell carcinoma. It was evaluated in a Phase 3 clinical trial in combination with sunitinib for patients with advanced or metastatic renal cell carcinoma. The drug is still in clinical development and has not been approved.
GM-CSF targets granulocyte-macrophage colony-stimulating factor, a cytokine involved in immune cell growth and activation. By targeting this factor, the monoclonal antibody may modulate immune responses in the tumor microenvironment. This mechanism was studied in the context of metastatic renal cell carcinoma.
GM-CSF is being developed by Immatics N.V., a biopharmaceutical company. Immatics is publicly traded under the ticker symbol IMTX. The company conducted a Phase 3 clinical trial of GM-CSF in patients with metastatic renal cell carcinoma.
GM-CSF is in Phase 3 clinical development. It has completed a Phase 3 trial in metastatic renal cell carcinoma, but it remains investigational and has not received regulatory approval. The completed trial enrolled 339 patients and was active-controlled, comparing the drug against an active treatment.
GM-CSF has one completed Phase 3 clinical trial, identified as NCT01265901. The trial, titled 'IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma,' enrolled 339 patients across multiple countries including the United States, France, Germany, and the United Kingdom. The study was randomized and active-controlled.
GM-CSF is also known as IMA901, which was the name used in the clinical trial. The Phase 3 trial NCT01265901 was titled 'IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma,' and it evaluated this drug in combination with sunitinib for metastatic renal cell carcinoma.