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autologous human tumor-derived HSPPC-96

Phase 3

Renal Cell Carcinoma | Small molecule | Oncology |Agenus Inc.|Last Updated: Sep 28, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment650

FDA Designations

No designations recorded

Clinical trial landscape

autologous human tumor-derived HSPPC-96 · 2 trials · 3 indications

Phase 3 1Phase 2 1
NCT00033904Survival Study Of Oncophage® vs. Observation In Patients With Kidney CancerRenal Cell Carcinoma
COMPLETED650 Analytics
PHASE3COMPLETED
Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
Renal Cell CarcinomaUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
autologous human tumor-derived HSPPC-96DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites76

Pre-Surgery Inclusion Criteria: * Primary-intact resectable renal cell cancer, without known distant metastasis and be scheduled to have surgery with curative intent; * Tumor size greater than or equal to 5 cm OR macroscopic nodes OR renal vein thrombus OR vena cava thrombus by radiologic evaluatio...

Countries:United StatesAustriaBelgiumCanadaFranceIsraelNorwayPolandSpainSwedenUnited Kingdom
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Frequently asked questions about autologous human tumor-derived HSPPC-96

What is autologous human tumor-derived HSPPC-96 used for?

Autologous human tumor-derived HSPPC-96 is an investigational cancer vaccine being studied for renal cell carcinoma and follicular lymphoma. It is derived from a patient's own tumor tissue and is designed to stimulate an immune response against the cancer. The drug is currently in clinical development and is not approved by the FDA.

Who makes autologous human tumor-derived HSPPC-96?

Autologous human tumor-derived HSPPC-96 is being developed by Agenus Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AGEN. The company is conducting clinical trials to evaluate the safety and effectiveness of this investigational therapy in oncology indications.

What phase is autologous human tumor-derived HSPPC-96 in?

Autologous human tumor-derived HSPPC-96 is in Phase 2 clinical development for lymphoma. A Phase 3 trial for renal cell carcinoma has been completed. The drug remains investigational and has not received FDA approval. Clinical trials are ongoing to further assess its potential as a cancer treatment.

What clinical trials is autologous human tumor-derived HSPPC-96 in?

Autologous human tumor-derived HSPPC-96 has been studied in two completed clinical trials. NCT00033904 was a Phase 3 survival study in patients with kidney cancer, enrolling 650 participants. NCT00081809 was a Phase 2 safety and effectiveness study in patients with indolent lymphoma, enrolling 35 participants.

Is autologous human tumor-derived HSPPC-96 the same as Oncophage?

Yes, autologous human tumor-derived HSPPC-96 is also known as Oncophage. The Phase 3 trial NCT00033904, titled 'Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer,' evaluated this drug in renal cell carcinoma. The drug is an investigational personalized cancer vaccine developed by Agenus Inc.