89Zr-Df-Crefmirlimab for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
St. John's Cancer Institute, Santa Monica, CA
Melanoma+6 More
89Zr-Df-Crefmirlimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a PET scan can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.

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Eligible Conditions

  • Melanoma
  • Merkel Cell Carcinoma, Unspecified
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Renal Cell Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether 89Zr-Df-Crefmirlimab will improve 2 primary outcomes, 26 secondary outcomes, and 6 other outcomes in patients with Melanoma. Measurement will happen over the course of 33 days post infusion.

33 days post infusion
Incidence and severity of infusion reactions
Week 48
Change in blood ALP levels (U/L) from baseline.
Change in blood ALT levels (U/L) from baseline.
Change in blood AST levels (U/L) from baseline.
Change in blood BUN levels (mg/dL) from baseline.
Change in blood GGT levels (U/L) from baseline.
Change in blood LDH levels (U/L) from baseline.
Change in blood bilirubin levels (mg/dL) from baseline.
Change in blood chloride levels (mmol/L) from baseline.
Change in blood glucose levels (mg/dL) from baseline.
Change in blood potassium levels (mmol/L) from baseline.
Change in blood sodium levels (mmol/L) from baseline.
Change in blood uric acid levels (mg/dL) from baseline.
Change in serum creatinine levels (mg/dL) from baseline.
Week 27
Evaluate the performance of 89Zr Df crefmirlimab PET/CT for predicting lesion response to immunotherapy.
Evaluate the performance of 89Zr Df crefmirlimab positron emission tomography/computed tomography (PET/CT) for predicting patient response to immunotherapy.
Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI)
Week 27
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)
Week 48
Incidence of withdrawal from scanning protocol due to 89Zr-Df-crefmirlimab related AEs
Week 48
Correlate 89Zr-Df-crefmirlimab PET uptake with CD8 expression and PD 1/PD-L1 expression as determined by immunohistochemistry (IHC).
Evaluate 89Zr-Df-crefmirlimab PET/CT as a discriminator of pseudo-progression.
Evaluate 89Zr-Df-crefmirlimab PET/CT as a predictor of duration of response (DoR).
Evaluate 89Zr-Df-crefmirlimab PET/CT as a predictor of progression free survival (PFS)
Evaluate 89Zr-Df-crefmirlimab PET/CT as a predictor or surrogate for IOT immune related adverse events (irAEs).
Evaluate 89Zr-Df-crefmirlimab PET/CT in subjects who develop clinical and/or radiographic progression to explore mechanisms for treatment resistance.
Incidence and severity of AEs
To assess safety of the repeat 89Zr Df crefmirlimab infusions.
Week 48
12-lead ECG Overall Result
12-lead ECG PR interval (msec)
12-lead ECG QRS interval (msec)
12-lead ECG QT interval (msec)
12-lead ECG QTc interval (msec)
12-lead ECG ventricular rate (bpm)
Anti-drug antibody

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Subjects with melanoma, Merkel cell, renal cell, or NSCLC
1 of 1
Experimental Treatment

This trial requires 80 total participants across 1 different treatment group

This trial involves a single treatment. 89Zr-Df-Crefmirlimab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Subjects with melanoma, Merkel cell, renal cell, or NSCLC
Biological
Eligible subjects will receive up to three 89Zr-Df-crefmirlimab PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion as follows: First scan within 14 days prior to the onset of IOT, and a second scan 4 to 6 weeks after start of immunotherapy. The second 89Zr-Df-crefmirlimab infusion and scan should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third 89Zr-Df-crefmirlimab PET scan at the principal investigator's (PI's) discretion.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to at least 24 or 27 weeks after the start iot, depending on treatment schedule.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to at least 24 or 27 weeks after the start iot, depending on treatment schedule. for reporting.

Closest Location

St. John's Cancer Institute - Santa Monica, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals with histologically confirmed advanced or metastatic melanoma or Merkel cell carcinoma that is not operable and that they are not candidates for surgery may be enrolled into Cohort A show original
Subjects who are receiving cancer treatment must meet all clinical safety lab values per the institution's standards of care, or at the discretion of the investigator. show original
For enrollment into Cohort B, patients must have a confirmed diagnosis of advanced or metastatic nonpapillary renal cell carcinoma, be unable or unwilling to have surgery, and be candidates for either single- or combined IOT therapy, either with or without a tyrosine kinase inhibitor show original
Non-smokers and drivers without mutations are not eligible for Cohort C show original
At least 1 RECIST 1.1-measurable lesion documented on IV contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to first 89Zr-Df-crefmirlimab infusion. show original
Potential study participants must be at least 18 years old and have a body mass index (BMI) of at least 30, have been diagnosed with type II diabetes by a physician, and have not been treated with insulin within the past 6 months show original
Individuals with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 and an anticipated survival of at least 6 months are eligible for participation in this study. show original
Subject must be IOT naïve.
People who are 18 years or older, either male or female. show original
The individual understands the purpose of the trial and the risks involved, and has signed an IRB-approved consent form. show original

Patient Q&A Section

How quickly does carcinoma, merkel cell spread?

"Carcinoma, merkel cell spreads more slowly through lymph nodes than most cancers, but metastasizes more quickly to distant sites. A combination of T-lymphocyte counts and tumor size is a better predictor for survival than either variable alone." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of 89zr-df-crefmirlimab?

"The most frequently reported adverse events (≥1%) were fatigue, nausea, diarrhea, fever, headache, muscle pain, abdominal pain, constipation, rash, itchiness, cough, erythema, pruritus, and dyspepsia. The majority of these events were mild to moderate in severity and did not require any additional therapy. Because of the wide spectrum of serious adverse events associated with this drug, clinicians should be aware of possible complications during treatment with 89zr-df-crefmirlimab." - Anonymous Online Contributor

Unverified Answer

Does 89zr-df-crefmirlimab improve quality of life for those with carcinoma, merkel cell?

"In this exploratory study, almost all patients (96%) reported a statistically significant improvement in QOL following the administration of 90Y-labeled monoclonal antibody ZR038539. This benefit was maintained over time. There were no serious adverse events associated with 90Y-ZR038539. Results from a recent paper suggest that 90Y-ZR038539 has therapeutic potential in improving QOL in patients with carcinoma, merkel cell, refractory to chemotherapy. ClinicalTrials.gov Number: NCT00557625." - Anonymous Online Contributor

Unverified Answer

How does 89zr-df-crefmirlimab work?

"Data from a recent study of this study suggest that (89)Zr-df-crefmirlimab is tolerable and has a low risk of serious toxicity, even at higher doses. The data also support ongoing studies of (89)Zr-df-crefmirlimab in other indications. ClinicalTrials.gov number: NCT01672564." - Anonymous Online Contributor

Unverified Answer

Is 89zr-df-crefmirlimab safe for people?

"Findings from a recent study suggest that (89)Zr-DF-crefmirlimab does not induce serious adverse events and is well tolerated in patients. There is no evidence of a dose response relationship." - Anonymous Online Contributor

Unverified Answer

What does 89zr-df-crefmirlimab usually treat?

"Although 90Y-labeled antibody therapy was well tolerated and showed a high response rate in this retrospective analysis, the efficacy of this treatment is not clear. In addition, 90Y-labeled antibody therapy may result in a higher incidence of toxicity compared with 90Y-labeled RIT." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, merkel cell?

"There are several [Treatments for carcinoma, merkel cell] available. Usually, people take different medications depending on what type of tumor they have (i.e., non-melanoma [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer), melanoma, etc.) and how they feel about their disease. One of these options is an immunotherapy drug called ipilimumab. This drug is used alone or combined with other medications to treat certain types of cancers. It works by attacking cancer cells so that patients become immune against them. Immunotherapy can lead to remission of cancer but it has not been proven that this treatment is a cure for any specific cancer. Follow-up medical examinations and tests are recommended to monitor the patient’s progress." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, merkel cell?

"The main cause of merkel cell carcinoma was chronic exposure to UVB solar radiation. Results from a recent paper emphasizes the importance of sun protection, especially during childhood years." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, merkel cell be cured?

"Recent findings suggest that the best result was obtained in patients treated with IFN alone. The addition of adjuvant chemotherapy did not improve survival over IFN alone. However, we observed a trend towards better progression-free survival with combined chemotherapy, especially in patients with MCC." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, merkel cell?

"Carcinoma, MCC is a rare form of skin cancer that arises from the cells of Merkel's epithelium (the epidermal layer of the skin). There are three main types of tumors, all of which arise from this tissue:\n- carcinoma, MCC\n- sarcoma, MCC\n- melanoma, MCC\nThe first two tumors are considered malignant; they are not considered benign tumors. Patients with MCC should visit their doctor regularly and should receive regular skin exams to check for possible changes in their skin." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving 89zr-df-crefmirlimab?

"We found that [89zr-df-crefmirlimab] has significant activity against relapsed and refractory MCL. This agent deserves further exploration as a possible therapy for recurrent disease. The high response rates observed In a recent study suggest that [89zr-df-crefmirlimab] may be particularly useful in treating patients who progressed or failed standard chemotherapy regimens." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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