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PROSTATE: METASTATIC: Pembro+Lenvatinib: 2nd or 3rd line chemo: KEYNOTE-365 ARM E

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

> or - 2nd line

Investigational Agent

Pembrolizumab, Lenvatinib

Drug Class

PD-1 inhibitor, VEG-F TKI

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Prostate Adenocarcinoma without small cell histology

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
  • Must provide a core or excisional biopsy from soft tissue or bone biopsy from soft tissue within 1 year of screening and after developing mCRPC
  • Has prostate cancer progression within 6 months prior to screening by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
  • Ongoing androgen deprivation with serum testoterone <50ng/dL
  • Stable doses of bone resorptive therapy
  • ECOG PS 0-1
  • Has previously received docetaxel for mCRPC. Prior treatment with one other chemotherapy is allowed. Up to 2 second-generation hormonal agents (eg. abiraterone, enzalutimide, etc.) are allowed. Prior ketoconazole is allowed. Docetaxel used more than once is considered as 1 therapy.
  • No diagnosis of immunodeficiency or systemic steroid therapy
  • No autoimmune disease within last 2 years
  • No known HBV/HCV/HIV
  • No known active CNS mets
  • No superscan bone scan
  • No active cardiovascular disease
  • No gastrointestinal malabsortion
  • No active hemoptysis
MOLECULARLY TARGETED: Metastatic; >/=2nd line; P2P; "SIGNATURE CTKI258AUS26"
Molecular phase II study to link targeted therapy to patients with pathway activated tumors: Module 2 - Dovitinib for patients with tumor pathway activations inhibited by dovitinib including tumors with mutations or translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk, and RET VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Advanced Cancer; non-squamous NSCLC (non-small cell lung), Melanoma, Ovarian, Thyroid, Multiple Myeloma, GIST (gastrointestinal stromal tumor), AML (acute myeloid leukemia)

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/=2nd line

Investigational Agent

Dovitinib (TKI258)

Drug Class

Angiogenesis inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

Mutations or transolocations in: FGFR PDGFR VEGF cKIT FLT3 CSFR1 Trk RET

Key Eligibility Criteria Details
Mutation or translocation of at least one of following genes:


FGFR 1/2/3, FLT3, cKIT,VEGFR 1/2, RET,
TrkA (NTRK1),PDGFRa/b,CSF-1R_
None of the following tumors:
Breast
RCC (kidney/renal)
Bladder
HCC (hepatocellular)
Endometrial
Squamous NSCLC
Heme malignancies (exceptFLT3 AML and MM)
At least one prior therapy for disease
ECOG 0-1
No brain mets
No anticoagulation
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