Metastatic Solid Cancer Clinical Trial

NCT04739618 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: BEDROCK 1001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This study seeks to estimate the potential efficacy of the study treatment, as well as the occurrence of adverse events.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of Non-ablative Cryosurgical Freezing and Multiplex Immunotherapy as determined by overall response rate of radiographic changes according to iRECIST criteria.

  Efficacy of Non-ablative Cryosurgical Freezing and Multiplex Immunotherapy as determined by overall response rate of radiographic changes according to iRECIST criteria.

  baseline to 8 weeks after end of treatment (approximately 5 months)

Secondary Outcomes (1)

• Efficacy of Non-ablative Cryosurgical Freezing and Multiplex Immunotherapy as determined by RECIST1.1 criteria

  baseline to 8 weeks after end of treatment (approximately 5 months)

Other Outcomes (8)

• Radiographic progression-free survival (rPFS)

  baseline to 8 weeks after end of treatment (approximately 5 months)

• Best overall response of confirmed PR or CR by independent radiology review

  baseline to 8 weeks after end of treatment (approximately 5 months)

• Time to progression (TTP) based on independent radiology review

  baseline up to 8 weeks after last treatment

Study Arms (1)

Single arm. Subjects receiving treatment.

EXPERIMENTAL

Efficacy of Non-ablative Cryosurgical Freezing and Multiplex Immunotherapy as determined by overall response rate of radiographic changes according to iRECIST criteria

Drug: Keytruda Injectable Product; Drug: Yervoy Injectable Product; Drug: GM-CSF; Procedure: Non-ablative Cryosurgical freezing

Interventions

Keytruda Injectable Product DRUG

PD-1 inhibitor antibody

Also known as: pembrolizumab

Single arm. Subjects receiving treatment.

Yervoy Injectable Product DRUG

Anti-CTLA-4 antibody

Also known as: ipilimumab

Single arm. Subjects receiving treatment.

GM-CSF DRUG

1 mL injected into each non-ablative cryosurgical freezing zone. Daily injection administered subcutaneously. 250 mcg daily injections for a total of 25 days after each treatment.

Also known as: sargramostim

Single arm. Subjects receiving treatment.

Non-ablative Cryosurgical freezing PROCEDURE

To induce immediate necrosis and necroptosis and a rim of injured cancer cells, thereby exposing a complete range of patient-specific tumor antigens that are specific to the treated subject.

Single arm. Subjects receiving treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial.
• Be ≥18 years of age on day of signing informed consent.
• Have a performance status of 0-2 on the ECOG Performance Scale.
• Have a life expectancy of 6 months or more as determined by treating physician.
• Have exhausted all other standard therapies; Have failed available therapy or are not a candidate for, or refuse available therapy (i.e. concerned with high adverse events rate in available therapy or outcome worse than disease); or failure of prior chemotherapy.
• Histologically-documented solid cancer. All subjects must submit their primary tumor or metastatic pathology specimens and laboratory and imaging reports to ImmunSYS where they will be centrally reviewed. Central ImmunSYS 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.
• Measurable disease as defined using iRECIST criteria and identified by radiographic imaging (Imaging should be current within the past three months of subject entering the study; if not repeat imaging must be done prior to enrollment.). In order to be eligible, the patient must have at least one metastatic bone and/or metastatic soft tissue site, lymph node site, and/or bone site with cancer mass measuring 1.5 cm or more in diameter based on soft tissue, lymph node, and/or bone lesions as defined by any of the following:
• Any soft tissue lesion defined by imaging deemed by the physician to be consistent with distant metastatic disease. For patients undergoing PSMA PET (prostate cancer patients only), only PSMA avid lesions that have a CT or MRI correlate consistent with metastasis will be counted as a site of metastasis.
• Metastatic lymph node disease defined by imaging. Any lymph node ≥1 cm in shortest dimension will be noted as involved with disease.
• 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 (prostate cancer patients only), only PSMA-avid lesions that are consistent with metastasis will be counted as a site of metastasis.
• The effects of the medications in this protocol on the developing human fetus are unknown. Any subject 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.
• Their partners will also be encouraged to use proper method of contraception.
• 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.

You may not qualify if:

• Is currently participating in 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.
• Has bone metastasis as the only site of disease.
• 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.
• Has a performance status of 3-5 on the ECOG Performance Scale.
• Has a known history of active TB (Bacillus Tuberculosis).
• Hypersensitivity to monoclonal antibodies such as Keytruda (pembrolizumab) or any of its excipients.
• 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.
• Is taking any current medication known to interfere with serum PSA concentration or radiographic extent of cancer (e.g., Enzalutamide, hormonal therapy) within 30 days for non-depot or 90 days for depot of start of treatment.
• 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.
• 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.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting.
• 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.
• 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.
• Has known recent (within 2 years) history of, or any evidence of active, non-infectious pneumonitis.
• Has an active infection requiring systemic therapy.

Sponsors & Collaborators

• ImmunSYS, LLC: lead

Study Sites (2)

Vincere Cancer Center

Scottsdale, Arizona, 85260, United States

Location

Florida Endovascular and Interventional

Miami Lakes, Florida, 33014, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

pembrolizumab; Ipilimumab; Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Gary Onik, M.D.

  ImmunSYS, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Male or female subjects greater than 18 years of age with histologically-proven metastatic cancer with at least one imaging- or histologically- proven metastases to lymph nodes, bone, or soft tissue.

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: February 4, 2021
• Study Start: March 4, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (2)