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Metastatic Prostatic AdenocarcinomaPhase 2NCT04090775

A Phase 2 Trial for Men With Metastatic Prostatic Adenocarcinoma

A Phase 2 study testing Opdivo Injectable Product, Yervoy Injectable Product and Cytoxan in people with Metastatic Prostatic Adenocarcinoma, run by Rampart Health, L.L.C. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study seeks to estimate the occurrence of adverse events related to the study treatment (Cryosurgical freezing and Intratumoral Combination Immunotherapy), as well as determine the potential efficacy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostatic Adenocarcinoma
What is being tested?
Opdivo Injectable Product, Yervoy Injectable Product and Cytoxan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
28 Jun 2019to 31 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 5.3.1 Be willing and able to provide written informed consent/assent for the trial.
  • 5.3.2 Be ≥18 years of age on day of signing informed consent.
  • 5.3.3 Have a performance status of 0-3 on the ECOG Performance Scale.
  • 5.3.4 Have a life expectancy of 6 months or more as determined by treating physician.
  • 5.3.5 Not a candidate for or refuses chemotherapy; or failure of prior chemotherapy.
  • 5.3.6 PSA >2 ng/mL at baseline.
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  • 5.3.7 Available archival tumor tissue for correlative studies. Submission of archival TRUS prostate biopsy tissue is required if available, in the form of representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 slides, with an associated pathology report. If archival prostate tissues are unavailable or cannot be obtained, a repeat TRUS prostate biopsy is not required for eligibility.
  • 5.3.8 Histologically-documented adenocarcinoma or mixed adenocarcinoma-neuroendocrine carcinoma of the prostate. All subjects must submit their primary tumor or metastatic biopsy pathology specimens and laboratory and imaging reports to Rampart Health where they will be centrally reviewed. Central Rampart Health pathologic review is not required for screening but rather for confirmation of diagnosis and histologic subtype of cancer. Local pathologic review is sufficient for eligibility determination.
  • 5.3.9 Measurable disease as defined by PCWG3 using iRECIST criteria and identified by radiographic imaging. In order to be eligible, the patient must have at least one metastatic bone and/or metastatic lymph node site(s) with cancer mass measuring 1 cm or more in diameter based on bone and/or soft tissue lesions as defined by any of the following:
  • Bone metastases defined by bone imaging. If the patient has technetium bone scan, and/or NaF PET performed, either study may be used for documenting metastases; both scans do not need to show the number of metastases required for study entry. For patients undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis.
  • Distant metastatic lymph node disease defined by imaging. A lymph node ≥1 cm in shortest dimension will be noted as involved with disease. Distant metastatic lymph nodes will be determined as any lymph nodes outside the confines of the true pelvis. For patients undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis.
  • Any other soft tissue lesion defined by imaging deemed by the physician to be consistent with distant metastatic disease. For patients undergoing PSMA PET, only PSMA avid lesions that have a CT or MRI correlate consistent with metastasis will be counted as a site of metastasis.
  • 5.3.10 The effects of the medications in this protocol on the developing human fetus are unknown. Men treated or enrolled on this protocol must agree to use adequate contraception prior to the first dose of study therapy, for the duration of the study participation, and for 120 days after the last dose of study therapy.
  • 5.3.11 Their partners should be encouraged to use proper method of contraception.
  • 5.3.12 Acceptable initial laboratory values within 14 days of treatment initiation according to the following: ANC ≥ 1500/µl; Hemoglobin ≥ 9.0 g/dL(prior transfusion permitted); Platelet count ≥ 100,000/µl; Creatinine ≤ 2.0 x the institutional upper limit of normal (ULN) OR creatinine clearance >30 ml/min; Potassium ≥ 3.5 mmol/L (within institutional normal range); Bilirubin ≤ 1.5 x ULN (unless documented Gilbert's disease); SGOT (AST) ≤ 2.5x ULN, or <5x ULN in patients with documented liver metastases; SGPT (ALT) ≤ 2.5x ULN or <5x ULN in patients with documented liver metastases; Albumin >2.5 mg/dL; Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. Deviation from these values is allowed at the discretion of the treating investigator.
  • 5.3.13 No active major medical or psychological problems that could be complicated by study participation.

Who cannot join

  • 5.4.1 Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • 5.4.2 Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment, with the exception of steroids for adrenal insufficiency in which case prednisone <10mg/day or its equivalent is allowed.
  • 5.4.3 Has a performance status of 4-5 on the ECOG Performance Scale.
  • 5.4.4 Has a known history of active TB (Bacillus Tuberculosis).
  • 5.4.5 Hypersensitivity to monoclonal antibodies such as nivolumab or any of its excipients.
  • 5.4.6 Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
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  • 5.4.7 Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • 5.4.8 Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Persisting toxicity related to prior therapy (NCI CTCAE v.5 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, Grade 2 anemia, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
  • 5.4.9 Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting.
  • 5.4.10 Has a known additional malignancy that is progressing or requires active treatment. Exceptions include carcinoid, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • 5.4.11 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), including but not limited to systemic or cutaneous lupus erythematosus, cutaneous psoriasis, psoriatic arthritis, rheumatoid arthritis, scleroderma, sicca syndrome, polymyalgia rheumatica, polyarteritis nodosa, granulomatous polyangiitis, microscopic polyangiitis, polyarteritis nodosa, temporal arteritis, giant cell arteritis, dermatomyositis, Kawasaki disease. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, hydroxychloroquine, etc.) is not considered a form of systemic treatment.
  • 5.4.12 Has known history of, or any evidence of active, non-infectious pneumonitis.
  • 5.4.13 Has an active infection requiring systemic therapy.
  • 5.4.14 Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • 5.4.15 Has known psychiatric or substance abuse disorder or any other condition that would interfere with cooperation with the requirements of the trial in the opinion of the Physician-investigator.
  • 5.4.16 Expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • 5.4.17 Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • 5.4.18 Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • 5.4.19 Has received a live vaccine within 30 days of planned start of study therapy.
  • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 30 days.
  • 5.4.20 Personal representative (family member or friend) withholds consent for any reason.
  • 5.4.21 Unable for any reason to understand the consent form and other written information and freely give written informed consent.
  • 5.4.22 Scores less than 14.5 (out of possible maximum of 20) on the UBACC Capacity to Consent Assessment Instrument.
  • 5.4.23 Does not re-sign the consent form a second time at least 24 hours after initial consent but before the treatment procedure.
  • 5.4.24 Hypersensitivity to Cyclophosphamide.
  • 5.4.25 Urinary outflow obstruction.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Antelope Valley Urology & Incontinence

    Lancaster, California, 93534

  • Ascension Providence Rochester Hospital

    Rochester, Michigan, 48307

Other trials in United States

About this study

Official title: A Phase 2 Trial of Cryosurgical Freezing and Intratumoral Combination Immunotherapy in Men With Metastatic Prostatic Adenocarcinoma

This study seeks to estimate the occurrence of adverse events related to the study treatment (Cryosurgical freezing and Intratumoral Combination Immunotherapy), as well as determine the potential efficacy.

Read the detailed description

Cryosurgical freezing will release intact antigens to prime the immune system. The study treatment immunotherapeutic drugs (PD-1 inhibitor monoclonal antibody nivolumab and anti-CTLA-4 monoclonal antibody ipilimumab, and cyclophosphamide) will then be sequentially injected directly into the cancer immediately following cryosurgical freezing. Oral low-dose cyclophosphamide will also be administered subsequently. It is speculated that neoantigens released from the cryoablated necrotic cancer will be available in the vicinity of the cryosurgical freezing field immediately following the procedure. Immature dendritic cells attracted to the injection site will internalize neoantigens to become activated to recognize cancer-specific antigenic proteins. The activated dendritic cells will recruit killer T-cells to the injection site to attack cancer cells, and then migrate through the lymphatic system to sites of metastases, targeting cancer-specific neoantigens and recruiting more killer T-lymphocytes to destroy other cancer cells harboring the precise antigenic epitopes (abscopal (bystander) effect). In this way, dendritic cells are capable of initiating cell-mediated systemic immune response in combination with cytotoxic killer T-cells. Regulatory T lymphocytes, which have been implicated in dampening or halting cell-mediated, antigen-specific immune responses, will be selectively depleted by anti-CTLA-4 monoclonal antibodies and low-dose cyclophosphamide. Intratumoral injection of the immunotherapeutic medications assists in stimulating and harnessing the local and systemic immune response. Oral cyclophosphamide prolongs the immune response. Using this combination of therapies, referred to as AbscopalRx1001, it is thought that a clinically significant systemic anti-cancer immune response might be elicited. Intratumoral injection of drugs will likely offer fewer side effects than systemic therapy.

Being tested
Opdivo Injectable Product, Yervoy Injectable Product, Cytoxan, Cryosurgical freezing (cryosurgery)

What participants receive

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

  • Opdivo Injectable ProductDrug

    Also called nivolumab

    Opdivo (nivolumab): PD-1 inhibitor antibody

    Injectable 10mg/mL, only 1 mL injected.

  • Yervoy Injectable ProductDrug

    Also called ipilimumab

    Yervoy (ipilimumab): Anti-CTLA-4 antibody

    Injectable 5mg/mL, only 1 mL injected.

  • CytoxanDrug

    Also called Cyclophosphamide

    Cytoxan (cyclophosphamide): Chemotherapy agent

    Both Injectable and Oral low dose:

    Injectable 250mg/m2, only 1 mL injected. Oral low dose cyclophosphamide: option of either 50mg once daily pill or 25mg twice daily pill for two weeks on, then two weeks off, then two weeks on again.

  • Cryosurgical freezing (cryosurgery)Procedure or surgery

    Also called Cryoablation

    Cryosurgery, also known as cryoablation, for prostate cancer works by freezing the cancer cells inside the prostate gland. Cryoablation will release intact antigens to prime the immune system.

Study groups in NCT04090775
Study groupRoleWhat they receive
Single arm. Subjects receiving treatment.OtherCryosurgical freezing and intratumoral combination immunotherapy as determined by the proportion of patients achieving serum PSA decline from baseline of at least 50%.
Receives: Drug: Opdivo Injectable Product; Drug: Yervoy Injectable Product; Drug: Cytoxan; Procedure: Cryosurgical freezing (cryosurgery)

What is being measured

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

  1. Primary endpoint: PSA decline

    Primary Endpoint: Efficacy of cryosurgical freezing and intratumoral combination immunotherapy as determined by the proportion of patients achieving serum PSA decline from baseline of at least 50%.

    Measured: baseline to 8 weeks after end of treatment (approximately 6 months)

Secondary outcomes (1)

  1. Efficacy of cryosurgical freezing and intratumoral combination immunotherapy iRECIST criteria

    Efficacy of cryosurgical freezing and intratumoral combination immunotherapy as determined by iRECIST criteria. Overall response rate as determined by PCWG3 using iRECIST radiographic response.

    Measured: baseline to 8 weeks after end of treatment (approximately 6 months)

Timeline

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

  1. First posted16 Sep 2019
  2. Study start28 Jun 2019
  3. Primary completion30 Jul 2020
  4. Study completion31 Jan 2022

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
Model description
Male subjects greater than 18 years of age with histologically-proven cancer of the prostate with at least one imaging- or histologically -proven metastasis to lymph nodes or bone.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04090775
Sponsor's protocol ID
ABSCOPAL 1001
Status last verified
Feb 2022
First submitted
9 Aug 2019
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Opdivo Injectable Product, Yervoy Injectable Product and Cytoxan in people with Metastatic Prostatic Adenocarcinoma, run by Rampart Health, L.L.C. 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 16 inclusion and 26 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: finished, as of the sponsor's last update on 21 Jun 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary endpoint: PSA decline (time frame: baseline to 8 weeks after end of treatment (approximately 6 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 NCT04090775.

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 21 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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