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WithdrawnNCT05728372Updated Oct 10, 2023

64Cu-DOTA Pembrolizumab for Imaging Metastatic Solid Tumors in Patients Receiving Stereotactic Body Radiation

An Early Phase 1 interventional study of Copper Cu 64-DOTA-pembrolizumab and Positron Emission Tomography in Metastatic Malignant Solid Neoplasm, sponsored by City of Hope Medical Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by City of Hope Medical Center · Early Phase 1, Interventional, and Treatment

Why this study was withdrawn
withdrawn per PI
Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This clinical trial tests how well using 64Cu-DOTA pembrolizumab (64CDP) with positron emission tomography (PET) scans works to find tumor cells in patients with cancers that have spread from where it first started to other places in the body (metastatic). 64CDP is a compound with pembrolizumab that is joined with a radioactive substance used for diagnostic purpose. Pembrolizumab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. Targeted drugs such as pembrolizumab may the improve uptake of the radioactive substance in tumor cells. 64CDP may improve ability to evaluate response to treatment in patients with solid tumors.

Read the detailed description

PRIMARY OBJECTIVES:

I. To describe toxicities of 64Cu-DOTA-pembrolizumab (64CDP) positron emission tomography, by evaluation of toxicities including: type, frequency, severity, attribution, time course, and duration.

II. To identify changes in 64Cu-DOTA-pembrolizumab (64CDP) uptake in radiated metastatic lesions pre- and post-SBRT.

OUTLINE:

Patients receive standard of care pembrolizumab intravenously (IV) at baseline. Patients then receive 64CDP IV days 1 and 29 on study. Patients undergo PET scan on days 2 and 30 on study. Patients also undergo standard of care SBRT days 8-18.

02

Conditions studied

  • Metastatic Malignant Solid Neoplasm
03

In context

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Documented informed consent of the participant and/or legally authorized representative.

    • Assent, when appropriate, will be obtained per institutional guidelines
  • Age: >= 18 years
  • Karnofsky performance status (KPS) >=70
  • Patients with metastatic disease from a solid-tumor malignancy currently being treated with single-agent pembroilizumab, who have been referred for stereotactic body radiation therapy (SBRT) for consolidative local therapy or for oligo resistant/progressive disease
  • Sites that amenable to SBRT are located in lymph nodes, bone/spine, or lung
  • Brain metastases or cases with intra-cranial progression are allowed, but an additional extra-cranial site planned for SBRT is required
  • Absolute neutrophil count (ANC) >= 1000/mm\^3
  • Platelet count >= 50/mm\^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment
  • Total bilirubin =\< 1.5 x the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
  • Calculated creatinine clearance >= 30mL/min
  • Contraception:

    • Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of 64Cu-anti-PD1 [pembrolizumab]-NHS-DOTA for women);
    • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug

Exclusion criteria

Exclusion Criteria:

  • Patient planned to stop Pembrolizumab at time of referral for SBRT
  • Patient unable to tolerate positron emission tomography (PET) scan even with anxiolytic medications
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Vaccination with live attenuated vaccines within 4 weeks of study agent administration except forthcoming COVID-19 vaccines
  • Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration with the exception of:

    • Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection);
    • Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent;
    • Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, CT scan premedication)
  • Female patients who are lactating or have a positive pregnancy test during the screening period
  • Infection requiring systemic antibiotic therapy within 14 days prior to start of study treatment
  • Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment (64CDP PET)

    Patients receive standard of care pembrolizumab IV at baseline. Patients then receive 64CDP IV days 1 and 29 on study. Patients undergo PET scan on days 2 and 30 on study. Patients also undergo standard of care SBRT days 8-18.

    Drug: Copper Cu 64-DOTA-pembrolizumab · Procedure: Positron Emission Tomography · Radiation: Stereotactic Body Radiation Therapy

Interventions

  • DrugCopper Cu 64-DOTA-pembrolizumab

    Given IV

    Also known as: 64Cu-DOTA-pembrolizumab, 64Cu-labeled Pembrolizumab, 64Cu-pembrolizumab, Copper Cu 64 Pembrolizumab

  • ProcedurePositron Emission Tomography

    Undergo PET scan

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

  • RadiationStereotactic Body Radiation Therapy

    Undergo SBRT

    Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

06

What researchers measure

Primary outcomes

  1. Dose Limiting Toxicities (DLT)

    Defined as any infusion-related reactions, hematologic or non-hematologic toxicities that occur during the first 3 days post administration of study drug that are possibly related to protocol therapy. DLT adverse events will be monitored continuously. Toxicities will be summarized in terms of type, severity, time of onset, duration, and association with study treatment.

    Time frame: After administration of study treatment up to 1 month

  2. Changes in 64CDP uptake

    T-test to determine significance. T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT.

    Time frame: From baseline through study completion, an average of 6 weeks

  3. Change in standard-uptake-value (SUV-max)

    T-test to determine significance.

    Time frame: From baseline through study completion, an average of 6 weeks

  4. Incidence of adverse events

    Defined as any infusion-related reactions, hematologic or non-hematologic toxicities that occur during the first 3 days post administration of study drug that are possibly related to protocol therapy. Dose limiting toxicity (DLT) adverse events will be monitored continuously. Toxicities will be summarized in terms of type, severity, time of onset, duration, and association with study treatment.

    Time frame: After administration of study treatment up to 1 month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05728372
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 15, 2023
Start date
Aug 25, 2023 (estimated)
Primary completion
Nov 8, 2026 (estimated)
Completion
Nov 8, 2026 (estimated)
Last update
Oct 10, 2023

Study contacts

Sagus Sampath
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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