AzTrials
AzTrials

Hematopoietic and Lymphoid Cell NeoplasmPhase 1NCT04605614

64Cu-DOTA-pembrolizumab PET for the Study of PD1 Expression

A Phase 1 study testing Copper Cu 64-DOTA-pembrolizumab, Pembrolizumab and Positron Emission Tomography in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This phase I trial evaluates the best dose and side effects of copper (64Cu)-DOTA-pembrolizumab positron emission tomography (PET) for the study of PD1 expression. 64Cu is a radiotracer that binds to a molecule, PD1, that is found on immune cells that are found in the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Copper Cu 64-DOTA-pembrolizumab, Pembrolizumab and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Apr 2022to 16 May 2022
Phase
Phase 1
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • Ability to undergo standard PET imaging
  • Plan to be treated with immunotherapy
  • Karnofsky performance status (KPS) >= 50%
  • 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
Show all 11Show fewer
  • Total bilirubin =< 1.5 x the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
  • Calculated creatinine clearance >= 30 mL/min
  • 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]-N-hydroxysuccinimide [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

Who cannot join

  • Prior exposure to pembrolizumab or other anti-PD1 therapy
  • Unable to tolerate PET scan
  • Any condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • 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 is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment. Subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor [GM-CSF]). Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
Show all 18Show fewer
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
  • Vaccination with live attenuated vaccines within 4 weeks of study agent administration
  • Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration
  • 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, computed tomography [CT] scan premedication)
  • Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis
  • Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 < 50%
  • Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients
  • Subject has history of primary immunodeficiency
  • Subject is positive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B, or active hepatitis A or C
  • 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)

About this study

Official title: A Phase I Study of 64Cu Pembrolizumab PET Imaging for In Vivo Expression of PD1

This phase I trial evaluates the best dose and side effects of copper (64Cu)-DOTA-pembrolizumab positron emission tomography (PET) for the study of PD1 expression. 64Cu is a radiotracer that binds to a molecule, PD1, that is found on immune cells that are found in the tumor. PD1 is short for 'programmed cell death protein 1'. When 64Cu-DOTA-pembrolizumab is injected into the patient's bloodstream, the 64Cu-pembrolizumab travels throughout the body and sticks to any tumor that has PD1 positive immune cells. Identifying the expression of PD1 in the tumor may help assess whether patients will respond to immunotherapy, and may detect clusters of immune cells when they are still too small to be detected by other Food and Drug Administration (FDA) approved techniques.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess safety and tolerability of unlabeled pembrolizumab followed by 64Cu-tetraxetan (DOTA)-pembrolizumab positron emission tomography, at each dose level, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration.

SECONDARY OBJECTIVES:

  1. Generate initial estimates of the biodistribution of the 64Cu-DOTA-pembrolizumab and the preferred dose of cold antibody.

II. Determine the dose of pre-administered unlabeled pembrolizumab that improves image quality by qualitative assessment by the radiologist of 64Cu-DOTA-pembrolizumab.

III. Evaluate the performance of 64Cu-DOTA-pembrolizumab in detecting tumor lesions.

OUTLINE: This is a dose-escalation study of 64Cu-DOTA-pembrolizumab.

Patients receive pembrolizumab intravenously (IV) over 30 minutes, and within 6 hours also receive 64Cu-DOTA-pembrolizumab via slow IV push over > 1 minute on day 0. Patients then undergo PET over 60 minutes on day 1.

After completion of study treatment, patients are followed up for 3 days.

Being tested
Copper Cu 64-DOTA-pembrolizumab, Pembrolizumab, Positron Emission Tomography
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • Copper Cu 64-DOTA-pembrolizumabRadiation

    Given IV

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET

Study groups in NCT04605614
Study groupRoleWhat they receive
Treatment (pembrolizumab, 64Cu-DOTA-pembrolizumab, PET)ExperimentalPatients receive pembrolizumab IV over 30 minutes, and within 6 hours also receive 64Cu-DOTA-pembrolizumab via slow IV push over > 1 minute on day 0. Patients then undergo PET over 60 minutes on day 1.
Receives: Radiation: Copper Cu 64-DOTA-pembrolizumab; Biological: Pembrolizumab; Procedure: Positron Emission Tomography

What is being measured

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

  1. Incidence of adverse events

    Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 5.0. Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study agent(s) and reversibility or outcome.

    Measured: Up to 3 days

  2. Dose limiting toxicity

    Measured: During the first 3 days post the administration of radiolabeled pembrolizumab

Secondary outcomes (1)

  1. Detection of lesions in the body by 64Cu-DOTA-pembrolizumab positron emission tomography

    Measured: Up to 3 days

Timeline

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

  1. First posted28 Oct 2020
  2. Study start15 Apr 2022 (estimated)
  3. Primary completion16 May 2022
  4. Study completion16 May 2022

Why it stopped: slow accruals

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04605614
Sponsor's protocol ID
20080
Other IDs
NCI-2020-07955, 20080, P30CA033572
Status last verified
Aug 2026
First submitted
22 Oct 2020
Last updated
12 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Copper Cu 64-DOTA-pembrolizumab, Pembrolizumab and Positron Emission Tomography in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center.

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 11 inclusion and 18 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: withdrawn, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

Incidence of adverse events (time frame: Up to 3 days). The study lists 2 primary outcomes in all. 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 NCT04605614.

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 12 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in