RecruitingMetastatic Cancer
Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Participants with metastatic cancer who are taking anti-PD-1 or anti-PD-L1 therapy will be enrolled to assess the safety of and find the optimal dose for radioactive imaging agents and to explore whether these agents will make current drug therapies work better. Up to 60 participants will be enrolled and can expect to be on study for up to 9 months.
Sponsor: University of Wisconsin, Madison
You may qualify if…
- ✓ 1. Participant must be informed of the investigational nature of the study and must be able to sign a written informed consent.
- ✓ 2. Participants with histologically or cytologically confirmed squamous cell carcinoma thought to originate from the head and neck region (HNC).
- ✓ 3. Participants must have metastatic solid malignancy, non-hematological.
- ✓ 4. Participants must be under treatment with one of the following FDA-approved standard-of-care anti-PD-1 or anti-PD-L1 therapies: Pembrolizumab (Keytruda; anti-PD-1 antibody), Nivolumab (Opdivo; anti-PD-1 antibody), Atezolizumab (Tecentriq, anti-PD-L1 antibody), Avelumab (Bavencio; anti-PD-L1 antibody), Durvalumab (Imfinzi; anti-PD-L1 antibody), Cemiplimab (Libtayo; anti-PD-1 antibody), Dostarlimab (Jemperli; anti-PD-1 antibody). Participants may be on additional FDA-approved immunotherapy treatments including anti-CTLA4 therapies or anti-LAG-3 therapies in addition to the anti-PD-1 or anti-PD-L1 backbone therapy. The specific additional therapies allowed are: Ipilimumab (Yervoy; anti-CTLA4 antibody), Tremelimumab (Imjudo; anti-CTLA4 antibody), or Relatlimab (Opdualag; anti-LAG-3).
- ✓ 5. Participants must have stable disease or concern for progression of their disease on most recent imaging scans yet be continuing on anti-PD1 or anti-PD-L1 therapy, per the treating physician. Participants may continue on anti-CTLA-4 or anti-LAG-3 ICIs if they have already been taking these when assessed to have stable or potentially progressive disease on most recent imaging. Subjects may also discontinue anti-CTLA-4 or anti-LAG-3 ICIs and remain eligible as long as they meet above criteria and continue the anti-PD-1 or anti-PD-L1 component of therapy that they have already been taking.
- ✓ 6. Participants must have at least one evaluable (measurable) tumor that is radiographically detectable.
- ✓ 7. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- ✓ 8. Participants must have a life expectancy of at least 6 months.
You may not qualify if…
- ✕ 1. Other concurrent severe and/or uncontrolled concomitant medical or psychiatric conditions (e.g., active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol, per investigator discretion.
- ✕ 2. The participant is taking strong inducers or inhibitors of CYP450 enzymes or drug transporters that cannot be held from at least 30 days prior to administration of 86Y-NM600 through the final 90Y-NM600 infusion without any expected adverse events. Examples include: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, phenobarbital, phenytoin, rifampicin, and glucocorticoids.
- ✕ 3. Chemotherapy, radiotherapy, or major surgery within 3 weeks prior to study enrollment (this will be greater than 5 weeks prior to 90Y-NM600 therapy).
- ✕ a. For patients receiving prior radiation therapy, the dose to tumor, kidneys, liver, and bone marrow must be recorded, if available.
- ✕ 4. The participant is pregnant, breastfeeding, or expecting to conceive or could impregnate someone within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
- ✕ 5. Any ongoing or active infection, including active tuberculosis, hepatitis B or C, or known infection with the human immunodeficiency virus (HIV) that is not well controlled (undetectable viral load by PCR) by anti-retroviral therapy.
- ✕ 6. Concurrent treatment with any other systemic anti-cancer or investigational agents other than an anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-LAG-3 antibody. Subjects cannot be receiving concomitant chemotherapy, experimental therapy or any other therapy not otherwise outlined by the trial for the purposes of anti-cancer treatment.
- ✕ b. Palliative external beam radiation therapy may be delivered to patients during this study if deemed necessary and safe by the treating physician.
Where it's recruiting
Wisconsin
Madison
Source: ClinicalTrials.gov · NCT07197671 · last updated 2026-08-19