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AGCT1532: Phase 3 Accelerated BEP Trial: A Randomized Phase 3 trial of Accelerated vs Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors

Clinical Trial Details

Standard treatment for advanced germ cell tumors includes three chemotherapy drugs called BEP (Bleomycin, Etoposide, and cisPlatin). BEP is given with a drug called pegfilgrastim or filgrastim which makes white blood cells grow. These drugs are given over the course of 3 weeks. Previous research has been done in studying BEP to improve the outcome of patients with poor-risk GCTs. One method that was tried is called dose intensification. This method works by giving the dose of chemotherapy drugs over a shorter length of time. Instead of the standard 3 week-cycle, patients would receive their treatment in a 2 week-cycle. By giving the drugs on a faster, or “accelerated” schedule, the study researchers wanted to see if this would help patients with poor-risk GCTs. The patients on the accelerated therapy in these previous studies did not experience more side effects than would be expected for standard BEP. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen using the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental.The overall goal of this study is to determine whether accelerated BEP will be effective and well-tolerated for patients with advanced GCTs. We don’t yet know if accelerated treatment is helpful in advanced GCTs and we are hoping this study will answer that question. 

Key Eligibility: 
  • Age 11 years and 45 years on the date of randomization
  • Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or exceptionally raised tumour markers (AFP 1000ng/mL and/or HCG 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently 
  • Primary arising in testis, ovary, retro-peritoneum, or mediastinum 
  • Metastatic disease or non-testicular primary 
  • Study treatment both planned and able to start within 14 days of randomization
  • Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments 
  • Able to provide signed, written informed consent 
  • Detailed eligibility reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan


June Greenberg, RN
(212) 746-2651

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group

Adult , Pediatric