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Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy The Cxbladder Monitoring Study Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Locally Advanced and Metastatic Urothelial Carcinoma Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium Application of UCAD for Diagnosing Urothelial Carcinoma. A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma EGCG Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells A Trial of Cabazitaxel for Advanced Transitional Cell Carcinoma (TCC) Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC Weekly TP-HDFL in the Treatment of Advanced TCC Detecting Transitional Cell Carcinoma From Haematuria Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU) Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma Vasculogenic Mimicry in Urothelial Carcinoma Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma DNA Methylation and Urothelial Carcinoma JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin DNA Methylation and Arsenic-associated Urothelial Carcinoma Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.

Brief Title

Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors

Official Title

Pilot Evaluation of Focused Ultrasound Ablation and Focused Ultrasound Ablation Plus PD-1 Antibody Blockade in Advanced Solid Tumors

Brief Summary

      This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with
      and without PD-1 blockade and with and without intratumoral poly-ICLC. A device called the
      Echopulse will be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts
      depending on their disease and treatment status. In Cohort 1, patients will receive FUSA
      therapy while receiving PD-1 blockade therapy as part of standard clinical care treatment. In
      Cohort 2, patients who discontinue or are ineligible for PD-1 blockade therapy will undergo
      FUSA without concurrent systemic therapy, with the goal of utilizing the FUSA to boost the
      innate immune response. The optional secondary regimen will combine FUSA (+/- PD-1 blockade)
      with intratumoral poly-ICLC.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

To assess the safety and toxicity of FUSA administered alone or in combination with PD-1 antibody blockade.

Secondary Outcome

 To estimate the proportion of patients with increased CD8+ T cell infiltration, after spot FUSA, in untreated metastasis, when available.

Condition

Melanoma

Intervention

Echopulse

Study Arms / Comparison Groups

 Cohort 1, primary regimen (Regimen 1a)
Description:  FUSA therapy and standard of care PD-1 blockade. FUSA therapy will be administered on day 8.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

32

Start Date

November 21, 2019

Completion Date

June 30, 2025

Primary Completion Date

December 31, 2024

Eligibility Criteria

        Inclusion Criteria:

          1. Age ≥18 years.

          2. Advanced solid tumor with measurable disease.

          3. Subject must have failed or have contraindication to standard therapies.

          4. For Cohort 1, primary regimen (Regimen 1a): Patients with advanced solid malignancy
             for which PD1 or PDL1 antibody monotherapy administered on a 3-week schedule is
             FDA-approved for treatment, who have one or more tumor deposits that are accessible to
             focused ultrasound treatment, and who are eligible to receive (or to continue to
             receive) PD1 or PDL1 blockade therapy. Uveal melanoma patients are not eligible for
             Regimen 1a.

             Note: Participants eligible for this regimen may receive the primary protocol therapy
             (Regimen 1a) concurrent with PD1/PDL1 antibody therapy if:

               -  Progressive Disease: subjects with progressive disease following PD1/PDL1
                  antibody therapy are eligible for this cohort if it is clinically appropriate for
                  them to continue on systemic PD1/PDL1 antibody per the treating clinician even if
                  they did not begin treatment on this trial. Examples may include a patient with a
                  small new lesion but stable disease in other sites, or very slight tumor growth
                  in multiple sites, in a patient without other approved therapy options.
                  Participants who progress following PD1/PDL1 antibody therapy may undergo
                  interval resection of enlarging lesions and still be included in this cohort as
                  long as they have persistent unresectable disease that is accessible to FUSA
                  treatment.

               -  Response with persistent disease: subjects who have a clinical response (SD or
                  PR) and have residual lesion(s) accessible to FUSA treatment. Participants with
                  PR are only eligible if it is clinically appropriate for them to continue on
                  PD1/PDL1 therapy per the judgement of the treating clinician.

               -  Stable disease: The majority of clinical responses to PD1/PDL1 blockade occur
                  within 12 weeks but may occur much later. Routine clinical practice commonly
                  includes continuation of PD1 antibody therapy for 1-2 years for patients with
                  stable disease on that therapy. Thus, patients with SD after 12 weeks of PD1/PDL1
                  therapy per RECIST criteria may be eligible for Regimen 1a if their disease has
                  remained stable on therapy and if their treating provider recommends continuation
                  of PD1/PDL1 therapy even if they were not treated on this trial.

          5. For Cohort 1, secondary regimen (Regimen 2a): For those patients treated with primary
             regimen 1a, select participants may be enrolled in a secondary regimen. This would
             include participants in the following scenarios:

               -  Stable disease.

               -  Response in lesion treated in regimen 1, but persistent disease or progression in
                  a separate lesion.

               -  Initial partial response but still persistent disease at the treated lesion.

               -  Initial response followed by progression at treated lesion or separate site,
                  after discontinuation of PD-1/PD-L1 antibody. If there is a response and then
                  progression at the site treated in Regimen 1 and the residual tumor meets
                  inclusion criteria, this lesion may be re-treated on the secondary regimen.

               -  Participants with lesions unique from the lesion treated in regimen 1 may enroll
                  in regimen 2 and have additional lesion(s) treated, as long as they meet all
                  inclusion criteria requirements. Up to three lesions may be treated in the second
                  regimen.

             Patients enrolling to Regimen 2a must have a target lesion amenable to intratumoral
             injection with polyICLC per the treating clinician's discretion. The lesion(s) to be
             FUSA treated in regimen 2 do not need to include the lesion targeted in regimen 1. The
             patient must remain eligible for PD1/PDL1 Ab therapy.

          6. For Cohort 2, primary regimen (Regimen 1b): The following patient subsets would be
             eligible for the Cohort 2 primary regimen, as long as they have failed (progressed or
             not tolerated) or are not eligible for all effective available approved therapies
             known to confer clinical benefit:

               -  Patients with advanced solid malignancy for which PD1 or PDL1 blockade is not
                  FDA-approved.

               -  Patients with metastatic uveal melanoma

               -  Patients with advanced solid malignancies for which PD1 or PDL1 blockade is FDA
                  approved but who are not eligible to receive that therapy because of prior
                  failure, toxicity, baseline autoimmune disease, or frailty.

               -  Patients who previously responded to PD1/PDL1 therapy but then progressed, if
                  there are no other systemic therapies available to them.

             Patients who were previously undergoing PD-1 blockade therapy must not have received a
             dose within 4 weeks prior to FUSA treatment.

          7. For Cohort 2, secondary regimen (Regimen 2b): For those patients treated with primary
             regimen 1a or 1b, select participants may be enrolled in a secondary regimen. This
             would include participants in the following scenarios:

               -  Stable disease.

               -  Response in lesion treated in regimen 1, but persistent disease or progression in
                  a separate lesion.

               -  Initial partial response but still persistent disease at the treated lesion.

               -  Initial response followed by progression at the treated lesion after
                  discontinuation of PD-1/PD-L1 antibody. If there is a response and then
                  progression at the site treated in Regimen 1 and the residual tumor meets
                  inclusion criteria, this lesion may be re-treated on the secondary regimen. For
                  participants who progress at a site unique from the treated lesion, they may
                  enroll in Regimen 2 and have this new lesion treated, as long as they meet all
                  inclusion criteria requirements.

               -  Participants with lesions unique from the lesion treated in regimen 1 may enroll
                  in regimen 2 and have additional lesion(s) treated, as long as they meet all
                  inclusion criteria requirements. Up to three lesions may be treated in the second
                  regimen.

             Patients enrolling to Regimen 2b must have a target lesion amenable to intratumoral
             injection with polyICLC per the treating clinician's discretion. The lesion to be FUSA
             treated in regimen 2 does not need to be the same lesion targeted in regimen 1.
             Crossover from primary regimen 1a is allowed if the patient is no longer eligible for
             continued PD1/PDL1 Ab therapy (e.g. due to autoimmune toxicity), and if there is no
             other effective systemic therapy option. The length between the FUSA treatments in
             regimen 1 and regimen 2 should be no less than 6 weeks. Patients who experienced an
             unanticipated device effect in the primary regimen are not eligible for the secondary
             regimen.

          8. One or more dermal, subcutaneous or nodal metastases from an advanced solid tumor. The
             metastases need to be accessible for FUSA and for biopsy.

             For FUSA:

             The targeted lesion(s) must be visible by ultrasound imaging and meet the following
             criteria. Brain lesions may not be targeted for treatment.

               -  Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be
                  treated with FUSA.

               -  The target treatment area needs to be contained within a region at least 5 mm
                  from the skin surface and less than or equal to 23 mm from the skin surface.

               -  The target treatment area must be at a safe distance from all critical
                  structures, including but not limited to ribs or other bony structures, vital
                  organs, named blood vessels or nerves.

               -  The critical structures, with the exception of the skin, will not be in the
                  pre-focal ultrasound path.

               -  The anterior-posterior dimension of the treatment area by US should be no less
                  than 9mm.

             For Biopsies:

             Biopsies may be completed with or without image guidance.

          9. Lesions that have been selected for focused ultrasound or lesions that have been
             selected for biopsies as untreated controls may have been previously radiated
             provided:

               -  The tumor site that was previously radiated has progressed.

               -  A baseline biopsy of the tumor site is obtained following progression and prior
                  to study entry.

         10. ECOG performance status 0-2.

         11. Subjects with brain metastases may participate if all of the following are true:

               -  There has been no evident growth of any brain metastasis since the most recent
                  treatment

               -  No brain metastasis is > 2 cm in diameter at the time of registration.

               -  Neurologic symptoms have returned to baseline,

               -  There is no evidence of new or enlarging brain metastases,

               -  Subjects are not using steroids for at least 7 days prior to registration.
                  Regardless of dose, however, subjects who are on a steroid taper for management
                  of brain metastases are not eligible until 7 days after completion of that
                  steroid taper.

               -  Brain metastases will not be targeted for FUSA treatment.

         12. Adequate organ function

         13. Ability and willingness to give informed consent.

        Exclusion Criteria:

        A subject will be excluded from participating in the trial if the subject:

          1. Has received the following medications or treatments at any time within 3 weeks of
             study day 1:

               1. Immune therapies including:

                    -  interferon (e.g. Intron-A®),

                    -  checkpoint blockade therapies other than anti-PD-1/PD-L1 antibodies,

                    -  antibodies to costimulatory molecules (e.g. CD27, CD137),

                    -  small molecule immune therapies (e.g. IDO1 inhibitor)

               2. Cytotoxic chemotherapy for cancer

          2. Has received the following medications or treatments at any time within 4 weeks of
             study day 1:

               1. Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be
                  used ≥ 1 week prior to registration)

               2. Allergy desensitization injections

               3. High doses of systemic corticosteroids, with the following qualifications and
                  exceptions:

                    -  Daily doses of 10 mg or less prednisone (or equivalent) per day administered
                       parenterally or orally are allowed in patients with normal adrenal and
                       pituitary function.

                    -  In patients with adrenal or pituitary insufficiency replacement steroid
                       doses are allowed.

                    -  Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low
                       doses (less than 500 mcg fluticasone per day, or equivalent)

                    -  Topical and nasal corticosteroids are acceptable.

               4. Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)

               5. Interleukins (e.g. Proleukin®)

               6. Any investigational therapeutic agent (participation in the UVA AM004 clinical
                  trial is permitted)

               7. Targeted therapies specific for mutated BRAF or for MEK

               8. Live vaccine

          3. Has a known addiction to alcohol or drugs and is actively taking those agents, or has
             recently (within 1 year) taken these agents or has ongoing illicit IV drug use.

          4. Is HIV positive or has evidence of active Hepatitis B or C virus with some exceptions.

          5. Is currently receiving nitrosoureas or has received this therapy within the preceding
             6 weeks

          6. Is pregnant or breastfeeding. Female participants of childbearing potential must have
             a negative pregnancy test obtained within 2 weeks prior to registration. Males and
             females must agree, in the consent form, to use effective birth control methods during
             the course of treatment and following treatment in accordance with the labeling
             guidelines for each approved therapy.

          7. Has a medical contraindication or potential problem in complying with the requirements
             of the protocol in the opinion of the investigator.

          8. Has an active infection requiring systemic therapy.

          9. Has Class III or IV heart disease as classified according to the New York Heart
             Association.

         10. Has had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy,or
             autoimmune disorders with visceral involvement. Participants with an active autoimmune
             disorder requiring these therapies are also excluded.

             Note: The following are not exclusionary:

               -  The presence of laboratory evidence of autoimmune disease (e.g. positive ANA
                  titer) without symptoms

               -  Clinical evidence of vitiligo

               -  Other forms of depigmenting illness

               -  Mild arthritis requiring NSAID medications

               -  A history of immune-related adverse events with immune therapy, if the
                  immune-related adverse events have resolved to grade 1 or lower.

         11. History of another cancer

             Note: the following diagnoses are exceptions and are permitted as long as they have
             been treated successfully and without clinical evidence of disease:

               -  Any cancer that has been treated successfully, without evidence of subsequent
                  recurrence or metastasis for over 5 years

               -  Any cancer without distant metastasis that has been treated successfully, without
                  evidence of recurrence or metastasis for over 2 years

               -  Squamous cell cancer of the skin without known metastasis

               -  Basal cell cancer of the skin without known metastasis

               -  Carcinoma in situ of the breast (DCIS or LCIS)

               -  Carcinoma in situ of the cervix

         12. 12) Previous treatment with polyICLC within 4 weeks. If a subject was previously
             treated with intratumoral polyICLC and experienced a significant (grade ≥3) toxicity
             related to the polyICLC treatment, the tumor that was treated should not be re-treated
             as part of this protocol.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lynn Dengel, MD, MSc, 434-982-1901, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04116320

Organization ID

21850


Responsible Party

Sponsor-Investigator

Study Sponsor

Craig L Slingluff, Jr

Collaborators

 Theraclion

Study Sponsor

Lynn Dengel, MD, MSc, Principal Investigator, University of Virginia


Verification Date

February 2023