A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)
VIEW TRIAL ON CLINICALTRIALS.GOVBiliary Tract Cancer, Cholangiocarcinoma; Gallbladder cancer
Stage 4
Phase 2
Open to Enrollment
2nd Line
Lenvatinib and Pembrolizumab
VEGF-R/FGFR inhibitor and PD-1 inhibitor
Manjari Pandey, MD
Merck Sharp & Dohme Corp
Adenocarcinoma
- Biliary Tract Cancer with 1 prior line of therapy
- Adjuvant therapy only counts as prior line if recurrence within 6 months of completing tx
- Measurable Disease per RECIST 1.1
- Archival tissue or newly obtained tissue available
- ECOG PS 0-1
- BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
- No evidence of malabsorption syndrome
- No evidence of major blood vessel involvement
- No clinically significant hemoptysis or tumor bleeding
- No arterial thromboembolism within 12 months
- No significant CAD within 12 months
- No prior lenvatinib or checkpoint inhibitor therapy
- Prior bevacizumab is allowed
- No proteinuria defined as Uprotein >1g/24 hours
- LVEF must be 55% or greater
- No chronic systemic steroid or immunosuppressive therapy
- No diagnosis of immunodeficiency
- No active CNS metastases
- No tumor involving the brain stem
- No active autoimmune disease that has required treatment within last 2 years
- No known HIV/HBV/HCV
A Randomized Phase II Trial of Atezolizumab With or Without Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer: Hoosier Cancer Research Network GU15-215
VIEW TRIAL ON CLINICALTRIALS.GOVBladder, Transitional Cell, Ureter, Urethral, Renal Pelvis, Urothelial
Stage 4
Phase 2
Open to Enrollment
1st Line
Atezolizumab and Bevacizumab
PD-L1 Antibody; VEGFR Antibody
Dan Vaena, MD
Hoosier Cancer Research Network
Transitional Cell Carcinoma
- ECOG PS 0-2
- Histological or cytological evidence of urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra
- Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease
- Evaluable untreated tumor tissue for biomarker analysis.
- Willing to undergo a core needle or excisional biopsy on-treatment.
- Measurable disease
- No prior chemotherapy for locally advanced or metastatic urothelial cancer
- Perioperative chemotherapy previously administered in the neoadjuvant and/or adjuvant setting is permitted
- Ineligible for cisplatin as defined by presence of one or more of the following:
- Impaired renal function [GFR ≥ 30 but ≤ 60 cc/min].
- Grade ≥ 2 Hearing Loss (hearing loss measured by audiometry of 25 dB at two contiguous frequencies)
- Grade ≥ 2 peripheral neuropathy
- ECOG Performance Status of 2
- Solitary Kidney
- No Active or untreated central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
- Evaluable or measurable disease outside the CNS
- No metastases to midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
- No history of intracranial or spinal cord hemorrhage
- No evidence of significant vasogenic edema
- No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose allowed
- No stereotactic radiation, whole-brain radiation within 4 weeks prior to Cycle 1 Day 1
- Patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy within 3 months prior to Cycle 1 Day 1 will be excluded
- No malignancies other than urothelial cancer within 5 years prior
- No history of autoimmune disease
- Known HIV, HBV, or HCV
- No inadequately controlled hypertension (defined as persistent systolic blood pressure (SBP) > 150 and/or diastolic blood pressure (DBP) > 100 mmHg)
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer
VIEW TRIAL ON CLINICALTRIALS.GOVBladder Cancer, Urothelial Cancer, Transitional Cell Carcinoma, Ureter, Renal Pelvis
Stage 4
Phase 3
Open to Enrollment
1st Line
Durvalumab, Tremelimumab
PD-L1 antibody, CTLA-4 antibody
Dan Vaena, MD
AstraZeneca
Transitional cell carcinoma
- Unresectable or metastatic transitional cell carcinoma or the urothelium (renal pelvis, ureters, urinary bladder, or urethra)
- Both transitional cell and mixed transitional/non-transitional cell histologies are permitted
- No prior 1st line therapy for metastatic disease
- Prior adjuvant therapy allowed if it has been >12 months since last therapy
- Prior local intervesical chemo or immune therapy is allowed if at least 28 days before study treatment
- Either cisplatin-eligible or cisplatin-ineligible but carboplatin eligible patients are allowed
- Measurable disease
- ECOG PS 0-1
- No prior immunotherapy with exception of BCG or antitumor vaccines
- No autoimmune disease requiring immunosuppression
- No untreated CNS disease
- No contraindications to platinum-based doublet chemotherapy
My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents
VIEW TRIAL ON CLINICALTRIALS.GOVOvarian, breast, CNS (GBM), Liver (HCC), Head and neck (SCCHN), colon, rectum (CRC) bladder, kidney (RCC), prostate, breast, gastric, pancreatic, melanoma (skin)
Stage 4
Phase 2
Open to Enrollment
2nd line or greater
Alectinib
ALK inhibitor
Ari VanderWalde
Genentech, Inc.
ALK gene rearrangements (by NGS or FISH), ALK mutations (NGS), ALK copy number gain (NGS)
- Metastatic solid tumor
- ALK alterations as follows
- ALK gene rearrangements by NGS or FISH using Vysis ALK Break Apart FISH Probe Kit
- Activating non-synonymous mutations in and around the ALK kinase domain by NGS
- ALK copy number gains by NGS
- Patients with melanoma and high ALK expression by IHC
- ECOG PS 0-2
- No prior treatment with any ALK inhibitor
- Following tumor types are not eligible
- Non-small cell lung cancer (NSCLC)
- Neuroblastoma
- Childhood tumors
An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification
VIEW TRIAL ON CLINICALTRIALS.GOVBladder, Breast, Lung, Colorectal, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Rectal, Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma
Stage 4
Phase 2
Open to Enrollment
Any (provided no curative therapy available)
Neratinib
pan-HER TKI
Lee Schwartzberg, MD
Puma Biotechnologies
HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer
- Histologically confirmed cancer for which no curative therapy exists
- Documented HER2 (ERBB2) or HER4 (ERBB4) mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
- At least one measurable or evaluable lesion
- LVEF >/=50%
- ECOG PS 0-2
- No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
- No symptomatic or unstable brain mets (stable are allowed)
- No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
- No uncontrolled cardiac disease
- No chronic diarrheal disorder
My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents
VIEW TRIAL ON CLINICALTRIALS.GOVbiliary cancer, cholangiocarcinoma, salivary gland, bladder, transitional cell carcinoma
Stage 4
Phase 2
Open to Enrollment
> 2nd line
trastuzumab/pertuzumab
anti-HER2 monoclonal antibodies
Ari VanderWalde, MD
Genentech, Inc.
HER2 overexpression or amplification
- One of the following malignancies
- Biliary cancer
- Salivary gland cancer
- Bladder cancer
- HER2 overexpression or amplification
- ECOG PS 0-2
- No prior treatment with any HER-2 directed therapy
- No active or untreated CNS metastastasis
- LVEF must be > or = 50%
A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.
VIEW TRIAL ON CLINICALTRIALS.GOVOvarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,
Stage 4
Phase 1
Open to Enrollment
Late line
COM-701, PD(L)-1 antibody
PVRIG monoclonal antibody, PD(L)-1 antibody
Dan Vaena, MD
Compugen
- Histologically or cytologically confirmed, metastatic solid malignancy
- Has exhausted all available standard therapy or not a candidate for standard therapy
- ECOG PS 0-1
- Prior PD-1/PD-L1 allowed
- No other malignancy within 2 years prior
- No active autoimmune disease requiring systemic therapy within last 2 years
- No chronic steroids or immunosuppressants.