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New treatment option for Penile Carcinoma
Official title Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma
ClinicalTrials.gov ID: NCT05526989
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for penile carcinoma.
Also referred to as Jemperli.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Provide written, informed consent to participate in the study and follow the study procedures
- Histologically confirmed stage III (unresectable) or stage IV penile cancer, as per American Joint Committee on Cancer (AJCC) staging system.
- Life expectancy \>12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 (ECOG performance status 2 can be included after discussion with PI)
- Measurable disease per iRECIST
You likely can't join if
- Use of an investigational agent or an investigational device within 4 weeks or within a time interval less than at least 5 half-lives of the...
- Active, known or suspected autoimmune disease requiring systemic treatment within the past 2 months or a documented history of clinically severe...
- History of allergy or hypersensitivity to study drug components
- History of organ transplant that requires use of immune suppressive agents
- Current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or...
- Prior surgery or radiotherapy encompassing \>20% of the bone marrow within 14 days of therapy. Patients must have recovered from all...
See the full eligibility criteria
Who can join
- Provide written, informed consent to participate in the study and follow the study procedures
- Histologically confirmed stage III (unresectable) or stage IV penile cancer, as per American Joint Committee on Cancer (AJCC) staging system.
- Life expectancy \>12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 (ECOG performance status 2 can be included after discussion with PI)
- Measurable disease per iRECIST
- Participants who have progressed or had tolerance problems to no more than one prior line of therapy in the locally advanced setting or post platinum-based chemotherapy, including in a neoadjuvant or adjuvant setting or...
- Participants must not have received any prior immune-oncology regimens, including but not limited to checkpoint inhibitors such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other...
- Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation
- Clinically significant toxic effect(s) of the most recent prior chemotherapy must be Grade 1 or resolved (except alopecia and sensory neuropathy that may be Grade 2).
- If the participant received major surgery or radiation therapy of \> 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
- Participants and their female partners of childbearing potential must agree and commit to use a highly effective form of contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the...
- Participants must not have known active brain metastases.
- Participants with treated brain metastases are eligible if they have neurologically returned to baseline (except for residual signs or symptoms related to the cns treatment) for at least 4 weeks prior to the first dose...
- Participant cannot be receiving any chronic systemic steroids (prednisone or equivalent) \> 20 mg daily, for at least 4 weeks prior to the first dose of study drug(s).
- Participants with small, untreated, asymptomatic central nervous system (CNS) metastases without associated edema, shift, or requirement for steroids are eligible after discussion with the Medical Monitor, i.e. the...
- No stereotactic radiation or craniotomy within 4 weeks of Cycle 1 Day 1
- No new central nervous system lesions on repeat radiographic imaging 4 weeks or more from last treatment
- No clinically significant symptoms secondary to brain metastases
- Participants must also consent to allow acquisition of existing formalin-fixed paraffin-embedded (FFPE) material (archival tumor tissue), either a block or unstained slides for planned correlative studies.
What rules you out
- Use of an investigational agent or an investigational device within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before administration of first...
- Active, known or suspected autoimmune disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive...
- History of allergy or hypersensitivity to study drug components
- History of organ transplant that requires use of immune suppressive agents
- Current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment.
- Prior surgery or radiotherapy encompassing \>20% of the bone marrow within 14 days of therapy. Patients must have recovered from all radiation-related toxicities.
- Active infection requiring systemic therapy; a known history of active tuberculosis.
- Has known active hepatitis B virus (HBV) infection (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C virus (HCV) infection (e.g., HCV ribonucleic acid [RNA] qualitative is detected)
- Has known immunodeficiency or active human immunodeficiency virus (HIV-1/2 antibodies) with CD 4 count \< 400 for in the past 6 months.
- Prolonged corrected QT interval (QTcF) \> 450 ms for men
- History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
- Unstable angina or myocardial infarction
- Congestive heart failure (New York Heart Association [NYHA] Class III or IV)
- Uncontrolled clinically significant arrhythmias
- Systolic BP \>140 mmHg or diastolic BP \>90 mmHg that has not been adequately treated or controlled. Need for \> 2 antihypertensive medications for management of hypertension (excluding diuretics)
- Must not have received a transfusion (platelets or red blood cells) ' 4 weeks prior to initiating protocol therapy.
- Must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol...
- Has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment.
- Must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Has experienced a Grade 3 or greater immune-related Adverse Event with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
- Has received a live vaccine within 30 days of initiating protocol therapy
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.