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This is an expanded access program (EAP) designed to provide access to Botensilimab and Balstilimab prior to drug registration by the applicable local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
This EAP is available for indications where there is reasonable scientific basis for use. Availability will depend on territory eligibility.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botensilimab | Drug | Administered via an intravenous (IV) infusion of Botensilimab + Balstilimab combination (BOT+BAL). |
| |
| Balstililmab | Drug | Administered via an IV infusion of Botensilimab + Balstilimab combination (BOT+BAL). |
|
Key Inclusion Criteria:
Note: Other defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Requests for expanded access use must be initiated by a treating physician. Physicians should contact: | Contact | +1-781-202-1614 | med.info@agenusbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Agenus Inc. | Study Director |
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| Label | URL |
|---|---|
| Agenus Medical Affairs | View source |
| Agenus Clinical Trials | View source |
| Agenus Access to Investigational Medicines Policy |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006528 | Carcinoma, Hepatocellular |
| D008545 | Melanoma |
| D012509 | Sarcoma |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000720935 | balstilimab |
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