Metastatic Prostate Neuroendocrine CarcinomaPhase 2CHAMPNCT04709276
A Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer
A Phase 2 study testing Nivolumab, Ipilimumab and Carboplatin in people with Metastatic Prostate Neuroendocrine Carcinoma and Metastatic Prostate Cancer, run by Andrew J. Armstrong, MD at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a combination of nivolumab, ipilimumab, cabazitaxel and carboplatin in men with neuroendocrine prostate cancer (NEPC) or other aggressive variants of prostate cancer (AVPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Neuroendocrine Carcinoma, Metastatic Prostate Cancer
- What is being tested?
- Nivolumab, Ipilimumab and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jun 2021to Aug 2028
- 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
- Neuroendocrine-like prostate cancer, based on histology OR based on clinical presentation as defined by meeting one of the two below criteria. All subjects must submit their primary tumor or metastatic biopsy pathology specimens to the Duke Cancer Institute where they will be centrally reviewed by Duke Pathology. Central Duke pathologic review is not required for screening but rather for confirmation of histologic subtype. Local pathologic review is sufficient for eligibility determination.
- Criterion 1: Presence of 1 of 3 histologically proven diagnoses: 1) Primary small cell carcinoma of the prostate, defined by classic histologic features such as small tumor cells with scanty cytoplasm, darkly stained nuclei with homogeneous chromatin pattern. The tumor cells do not form glandular structure but grow as solid sheets with frequent mitotic figures and necrosis; 2) Intermediate atypical carcinoma of the prostate, which has histologic features distinct from small cell carcinoma or adenocarcinoma. The tumor grows as solid sheets or vague glandular structures. The tumor cells have moderate amounts of cytoplasm and centrally located, round and regular nuclei with fine, granular and homogeneous chromatin. Mitosis and necrosis are absent; 3) mixed histology tumors of the prostate, containing both adenocarcinoma and neuroendocrine or small cell components.
- Criterion 2: Presence of histologically proven adenocarcinoma of the prostate without any sign of neuroendocrine or small cell histology that is radiographically progressing with the following poor risk features:
- Prior progression despite therapy with abiraterone acetate, darolutamide or apalutamide and/or enzalutamide.
- At least one of the following: 1) Visceral metastases; 2) Low PSA (<10 ng/mL) with either A. bulky lymphadenopathy or pelvic mass (>5 cm) or B. high volume (>20) bone metastases; 3) Short interval (<6mo) to CRPC following initiation of hormonal therapy 4) Pathogenic alterations in two of three genes: TP53, RB1, and PTEN. 5) Predominantly lytic bone metastases on imaging, 6) Presence of neuroendocrine markers on histology (positive staining of chromogranin A or synaptophysin) or in serum (abnormal high serum levels for chromogranin A or gastrin releasing peptide (GRP)) at initial diagnosis or at progression; 7) Any of the following in the absence of other causes: A. elevated serum LDH (>= IULN); B. malignant hypercalcemia; C. elevated serum CEA (>2x IULN).
- Available archival tumor tissue for pathologic review and correlative studies. Tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and/or blocks) to be sent to Duke.
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- Documented progressive metastatic CRPC as determined by the provider based on at least one of the following criteria:
- PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2.0 ng/mL. Note: If confirmed rise is the only indication of progression, a minimal starting value of 1.0 ng/mL is acceptable, unless pure small-cell carcinoma.
- Soft-tissue progression based on new lesions or growth of existing soft tissue metastases.
- Progression of bone metastasis with one or more new bone lesion(s) by imaging.
- Castrate levels of serum total testosterone (<50 ng/dl) OR ongoing documented ADT.
- These criteria are not required when pure small cell prostate cancer is present.
- Karnofsky performance status of 70 or higher.
- Acceptable initial laboratory values within 14 days of Cycle 1 Day 1
- Age >18
- Subjects with a partner who is a woman of child-bearing potential must agree to use one form of highly effective contraception as detailed in Section 8.3 of this protocol during the treatment period with cabazitaxel. Subjects receiving cabazitaxel or nivolumab must also refrain from donating sperm during this period.
- Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
- Life expectancy of over 3 months as determined by treating physician.
Who cannot join
- Has received prior therapy for prostate cancer with abiraterone or androgen receptor antagonists (e.g. enzalutamide darolutamide, apalutamide) within two weeks of study treatment initiation.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received other prior systemic anti-cancer therapy not otherwise addressed by other eligibility criteria including investigational agents within 4 weeks prior to study treatment initiation
- Prior receipt of cabazitaxel chemotherapy or 2 or more chemotherapy regimens in the mCRPC setting.
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
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- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- Has known active untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment greater than prednisone 10mg (or equivalent) for at least 14 days prior to first dose of study intervention.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known uncontrolled Human Immunodeficiency Virus (HIV) infection based on detectable HIV viral load and abnormal CD4 count of <350/mm3.
- Has a known active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Has a known active TB (Bacillus Tuberculosis) infection.
- Has ≥ Grade 2 neuropathy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known current psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Weill Cornell Medicine
New York, New York, 10022
About this study
Official title: A Phase II, Single Arm Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer (CHAMP)
The purpose of this study is to evaluate the safety and efficacy of a combination of nivolumab, ipilimumab, cabazitaxel and carboplatin in men with neuroendocrine prostate cancer (NEPC) or other aggressive variants of prostate cancer (AVPC). This study will also investigate biomarkers to gain a better understanding of how the drug combination of nivolumab, ipilimumab, cabazitaxel and carboplatin affects these types of prostate cancer and the immune system. Eligible subjects will receive up to 10 cycles of nivolumab, ipilimumab, carboplatin and cabazitaxel followed by maintenance nivolumab and ipilimumab. Subjects may continue receiving study drugs until cancer progression, severe toxicity, withdrawal of consent, 3 years from the initial dose of study drugs or study termination, whichever occurs earlier. Subjects will be followed for 3 years from the initial dose of study drugs.
- Being tested
- Nivolumab, Ipilimumab, Carboplatin, Cabazitaxel
- Keywords
- Neuroendocrine Prostate Cancer, Aggressive Variant Prostate Cancer, Chemoimmunotherapy, Nivolumab, Ipilimumab, Carboplatin, Cabazitaxel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-936558, MDX1106, ONO-4538
360 mg intravenously every 3 weeks
IpilimumabDrug
Also called BMS-734016, MDX010, MDX-CTLA4
1 mg/kg intravenously every 6 weeks
CarboplatinDrug
AUC 4 mg/ml per minute intravenously every 3 weeks for up to 10 cycles.
Subjects will also receive granulocyte-colony stimulating factor (G-CSF) therapy while receiving carboplatin.
CabazitaxelDrug
Also called JEVTANA
20 or 25 mg/m2 intravenously every 3 weeks for up to 10 cycles.
Subjects will also take prednisone by mouth at a dose of 10 mg daily and receive granulocyte-colony stimulating factor (G-CSF) therapy while receiving cabazitaxel.
| Study group | Role | What they receive |
|---|---|---|
| Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC) | Experimental | Subjects with neuroendocrine prostate cancer (NEPC) or aggressive variant prostate cancer (AVPC) will receive a combination of nivolumab, ipilimumab, carboplatin and cabazitaxel for up to 10 cycles of 21 days each. After carboplatin and cabazitaxel are discontinued, a combination of nivolumab and ipilimumab will be administered.
Nivolumab will be administered intravenously at a dose of 360 mg every 3 weeks.
Ipilimumab will be administered intravenously at a dose of 1 mg/kg every 6 weeks.
Carboplatin will be administered intravenously at a dose of AUC 4 mg/ml per minute.
Cabazitaxel will be administered intravenously at a dose of 20 or 25 mg/m2. Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Carboplatin; Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who are progression-free and alive (progression-free survival) at 6 months
Progression-free survival will be determined by immune modified or Prostate Cancer Working Group 3 (PCWG3)-defined RECIST 1.1 radiographic criteria.
Measured: 6 months
Secondary outcomes (12)
Proportion of subjects who are progression-free and alive (progression-free survival) at 12 months
Progression-free survival will be determined by immune modified or PCWG3-defined RECIST 1.1 radiographic criteria.
Measured: 12 months
Proportion of subjects who are progression-free and alive (progression-free survival) and without severe toxicity leading to treatment discontinuation at 6 and 12 months
Progression-free survival will be determined by immune modified or PCWG3-defined RECIST 1.1 radiographic criteria.
Measured: 6 and 12 months
Overall survival
Measured: 6, 12 and 24 months
Median overall survival
Measured: Through study completion (up to 3 years)
Describe the radiographic progression free survival (rPFS)
Radiographic progression free survival will be determined by immune modified PCWG3-defined RECIST criteria.
Measured: Through study completion (up to 3 years)
Describe the best radiographic response by immune modified PCWG3-defined RECIST radiographic response.
Radiographic response will be determined by immune modified PCWG3-defined RECIST criteria.
Measured: Through study completion (up to 3 years)
Describe the toxicities of nivolumab, and ipilimumab in combination with carboplatin and cabazitaxel using NCI CTC v5.0.
The toxicity and safety will be graded using NCI CTCAE v5.0.
Measured: Through discontinuation of carboplatin and cabazitaxel dosing (up to 30 weeks)
Describe the changes in the blood-based biomarker Prostate-Specific Antigen (PSA) over time
PSA
Measured: Through discontinuation of study drugs (up to 3 years)
Describe the changes in the blood-based biomarker chromogranin-A over time
chromogranin-A
Measured: Through discontinuation of study drugs (up to 3 years)
Describe the changes in the blood-based biomarker carcinoembryonic antigen (CEA) over time
CEA
Measured: Through discontinuation of study drugs (up to 3 years)
Describe the changes in the blood-based biomarker lactate dehydrogenase (LDH) over time
LDH
Measured: Through discontinuation of study drugs (up to 3 years)
Describe the changes in the blood-based biomarker alkaline phosphatase over time
alkaline phosphatase
Measured: Through discontinuation of study drugs (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start7 Jun 2021
- Primary completion26 Feb 2026
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew J. Armstrong, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Andrew J. Armstrong, MD, Duke University
- Investigators
- Andrew Armstrong, MD, ScM, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709276
- Sponsor's protocol ID
- Pro00106278
- Other IDs
- CA209-63X
- Acronym
- CHAMP
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2021
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Arm Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer (CHAMP)
- ClinicalTrials.gov ID
- NCT04709276
- Acronym / sponsor ID
- CHAMP / Pro00106278
- Keywords
- Neuroendocrine Prostate Cancer, Aggressive Variant Prostate Cancer, Chemoimmunotherapy, Nivolumab, Ipilimumab, Carboplatin, Cabazitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Andrew J. Armstrong, MDUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- Aug 2028 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of a combination of nivolumab, ipilimumab, cabazitaxel and carboplatin in men with neuroendocrine prostate cancer (NEPC) or other aggressive variants of prostate cancer (AVPC). This study will also investigate biomarkers to gain a better understanding of how the drug combination of nivolumab, ipilimumab, cabazitaxel and carboplatin affects these types of prostate cancer and the immune system. Eligible subjects will receive up to 10 cycles of nivolumab, ipilimumab, carboplatin and cabazitaxel followed by maintenance nivolumab and ipilimumab. Subjects may continue receiving study drugs until cancer progression, severe toxicity, withdrawal of consent, 3 years from the initial dose of study drugs or study termination, whichever occurs earlier. Subjects will be followed for 3 years from the initial dose of study drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC) | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: Carboplatin, Drug: CabazitaxelSubjects with neuroendocrine prostate cancer (NEPC) or aggressive variant prostate cancer (AVPC) will receive a combination of nivolumab, ipilimumab, carboplatin and cabazitaxel for up to 10 cycles of 21 days each. After carboplatin and cabazitaxel are discontinued, a combination of nivolumab and ipilimumab will be administered. Nivolumab will be administered intravenously at a dose of 360 mg every 3 weeks. Ipilimumab will be administered intravenously at a dose of 1 mg/kg every 6 weeks. Carboplatin will be administered intravenously at a dose of AUC 4 mg/ml per minute. Cabazitaxel will be administered intravenously at a dose of 20 or 25 mg/m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Neuroendocrine-like prostate cancer, based on histology OR based on clinical presentation as defined by meeting one of the two below criteria. All subjects must submit their primary tumor or metastatic biopsy pathology specimens to the Duke Cancer Institute where they will be centrally reviewed by Duke Pathology. Central Duke pathologic review is not required for screening but rather for confirmation of histologic subtype. Local pathologic review is sufficient for eligibility determination.
- Available archival tumor tissue for pathologic review and correlative studies. Tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and/or blocks) to be sent to Duke.
- Documented progressive metastatic CRPC as determined by the provider based on at least one of the following criteria:
- Castrate levels of serum total testosterone (<50 ng/dl) OR ongoing documented ADT.
- Karnofsky performance status of 70 or higher.
Key exclusion criteria (20 listed)
- Has received prior therapy for prostate cancer with abiraterone or androgen receptor antagonists (e.g. enzalutamide darolutamide, apalutamide) within two weeks of study treatment initiation.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received other prior systemic anti-cancer therapy not otherwise addressed by other eligibility criteria including investigational agents within 4 weeks prior to study treatment initiation
- Prior receipt of cabazitaxel chemotherapy or 2 or more chemotherapy regimens in the mCRPC setting.
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558, MDX1106, ONO-4538360 mg intravenously every 3 weeks | Drug | Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC) |
| IpilimumabAlso: BMS-734016, MDX010, MDX-CTLA41 mg/kg intravenously every 6 weeks | Drug | Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC) |
| CarboplatinAUC 4 mg/ml per minute intravenously every 3 weeks for up to 10 cycles. Subjects will also receive granulocyte-colony stimulating factor (G-CSF) therapy while receiving carboplatin. | Drug | Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC) |
| CabazitaxelAlso: JEVTANA20 or 25 mg/m2 intravenously every 3 weeks for up to 10 cycles. Subjects will also take prednisone by mouth at a dose of 10 mg daily and receive granulocyte-colony stimulating factor (G-CSF) therapy while receiving cabazitaxel. | Drug | Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC) |
Primary outcome
Proportion of subjects who are progression-free and alive (progression-free survival) at 6 months
Time frame: 6 months
Progression-free survival will be determined by immune modified or Prostate Cancer Working Group 3 (PCWG3)-defined RECIST 1.1 radiographic criteria.
12 secondary outcomes
Proportion of subjects who are progression-free and alive (progression-free survival) at 12 months
Time frame: 12 months
Proportion of subjects who are progression-free and alive (progression-free survival) and without severe toxicity leading to treatment discontinuation at 6 and 12 months
Time frame: 6 and 12 months
Overall survival
Time frame: 6, 12 and 24 months
Median overall survival
Time frame: Through study completion (up to 3 years)
Describe the radiographic progression free survival (rPFS)
Time frame: Through study completion (up to 3 years)
Describe the best radiographic response by immune modified PCWG3-defined RECIST radiographic response.
Time frame: Through study completion (up to 3 years)
Describe the toxicities of nivolumab, and ipilimumab in combination with carboplatin and cabazitaxel using NCI CTC v5.0.
Time frame: Through discontinuation of carboplatin and cabazitaxel dosing (up to 30 weeks)
Describe the changes in the blood-based biomarker Prostate-Specific Antigen (PSA) over time
Time frame: Through discontinuation of study drugs (up to 3 years)
Describe the changes in the blood-based biomarker chromogranin-A over time
Time frame: Through discontinuation of study drugs (up to 3 years)
Describe the changes in the blood-based biomarker carcinoembryonic antigen (CEA) over time
Time frame: Through discontinuation of study drugs (up to 3 years)
Describe the changes in the blood-based biomarker lactate dehydrogenase (LDH) over time
Time frame: Through discontinuation of study drugs (up to 3 years)
Describe the changes in the blood-based biomarker alkaline phosphatase over time
Time frame: Through discontinuation of study drugs (up to 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Armstrong, MD, ScM principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ipilimumab and Carboplatin in people with Metastatic Prostate Neuroendocrine Carcinoma and Metastatic Prostate Cancer, run by Andrew J. Armstrong, MD at 3 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 18 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who are progression-free and alive (progression-free survival) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.