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Penile CarcinomaPhase 2NCT05526989

Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

A Phase 2 study testing Dostarlimab and Niraparib in people with Penile Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Penile Carcinoma
What is being tested?
Dostarlimab and Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
28 Dec 2022to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 in combination with radiation therapy.
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  • 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 antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways, indoleamine 2,3-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or other cytokine therapies
  • 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 duration of the study until 6 months (female participants) and 3 months (male participants and their female partners), respectively, following the last dose of study drug. Female partner may use either an intrauterine device or hormonal contraception and continue until 3 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy 90 days months before signing the informed consent form (ICF) or a penectomy.
  • 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 of study drug(s).
  • 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 Principal Investigator.
  • 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.

Who cannot join

  • 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 dose of study drug.
  • 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 agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or with PI approval.)
  • 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.
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  • 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 therapy.
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Curtis Pettaway, MD, 713-792-3250, cpettawa@mdanderson.org

    Curtis Pettaway, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Robin Neubauer, 813-745-5604, Robin.Neubauer@moffitt.org

    Juskaran Chadha, DO

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy

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.

Being tested
Dostarlimab, Niraparib
Medical subject headings
Penile Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DostarlimabDrug

    Also called Jemperli

    300 mg Dostarlimb will be administered by IV, increasing to 1000 mg after cycle 4.

  • NiraparibDrug

    Also called Zejula

    200 mg Niraparib will be taken once daily by mouth days 1-21 of all cycles.

Study groups in NCT05526989
Study groupRoleWhat they receive
Dostarlimab and Niraparib treatmentExperimentalParticipants will be given 500 mg Dostarlimab IV every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks, along with 200 mg Niraparib by mouth once daily days 1-21 of all cycles.
Receives: Drug: Dostarlimab; Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    Overall response rate is defined as the number of patients with best overall response of complete response or partial response divided by total number of participants by immune Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1.

    Measured: Up to 24 months

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    Progression free survival is defined as the duration of time from the start of treatment to the first documentation of tumor progression or death.

    Measured: Up to 24 months

  2. Overall Survival (OS)

    Overall survival is defined as the duration of time from the start of treatment to death due to any cause.

    Measured: Up to 24 months

  3. Duration of Response (DOR)

    Duration of response is defined as the time from the date of disease response to the date of disease progression. Participants who do not experience disease progression will be censored at the date of last follow up or last visit.

    Measured: Up to 24 months

  4. Overall Response Rate (ORR)

    Overall response rate is defined as the number of participants with a best overall response of complete response or partial response per Response Evaluation Criteria in Solid tumors (RECIST)1.1 divided by the total number or participants.

    Measured: Up to 24 months

  5. Disease Control Rate (DCR)

    Disease control rate is defined as the percentage of patients who have achieved best overall response of complete response, partial response, or stable disease per Response Evaluation Criteria in Solid Tumors (RECIST)1.1.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start28 Dec 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05526989
Sponsor's protocol ID
MCC-21192
Status last verified
Dec 2025
First submitted
31 Aug 2022
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hatoum F, Souza GR, Johnson J, Miller J, Fazili A, Pettaway CA, Campbell MT, Neubauer R, Johns A, Mizelle SR, Kim Y, Chadha J, Zhang J, Jameel G, Oschmann E, Dhillon J, Moscu A, Janeway R, Harris W, Lu X, Spiess PE, Chahoud J. Phase 2 study of dostarlimab plus niraparib in stage III-IV recurrent or refractory Penile squamous cell carcinoma. Future Oncol. 2025 Dec;21(28):3619-3627. doi: 10.1080/14796694.2025.2577632. Epub 2025 Oct 30.

    PubMed 41163621

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab and Niraparib in people with Penile Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05526989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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