What side effects are associated with this type of intervention?

Common treatments for melanoma, such as immunotherapy (e.g., atezolizumab) and targeted therapy (e.g., vemurafenib and cobimetinib), have several known side effects. Atezolizumab can cause serious adverse events like limbic encephalitis, while vemurafenib and cobimetinib are associated with grade 3 or worse adverse events, including anemia and dermatitis acneiform. Serious adverse events in patients treated with these therapies can include febrile neutropenia, pneumonia, diarrhea, and acute kidney injury. These treatments can also lead to treatment discontinuation due to adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for melanoma, particularly focusing on immunotherapies and targeted therapies. Notable approvals include checkpoint inhibitors like nivolumab and pembrolizumab, which target PD-1, and combination therapies such as nivolumab plus ipilimumab. Targeted therapies for BRAF-mutant melanoma, such as vemurafenib and dabrafenib, have also been approved. While specific radiolabeled antibodies for PET/CT imaging like Zirconium Zr 89 crefmirlimab berdoxam are still under investigation, these existing treatments highlight the FDA's focus on innovative approaches to manage melanoma.

What other types of research exist?

Promising novel alternatives for melanoma patients in 2024 include Lutetium Lu-177 dotatate, which has shown significant treatment responses in combination with immunotherapy, and Pembrolizumab, an immune checkpoint inhibitor that has demonstrated efficacy in various trials. Additionally, investigational approaches such as the combination of Pembrolizumab plus Cetuximab and the use of multitargeted kinase inhibitors like Regorafenib are also noteworthy.

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Monoclonal Antibodies

Imaging with Zirconium Zr 89 Crefmirlimab Berdoxam for Cancer (iPREDICT Trial)

Phase 2

Waitlist Available

Led By Kim Margolin, MD

Research Sponsored by ImaginAb, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months

Subjects with histologically confirmed advanced or metastatic non-uveal/non-mucosal melanoma or merkel cell carcinoma (MCPyV positive and negative) who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment

Must not have

Bone-only disease without a measurable soft tissue component on conventional imaging (MRI, PET, CT)

Subjects with skin-only (cutaneous) lesions will be excluded from the tumor biopsy assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to at least 24 or 27 weeks after the start iot, depending on treatment schedule.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special imaging test to see if it can predict how well treatments are working for patients with serious types of cancer.

Who is the study for?

Adults with advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer who can't be cured by surgery. They should have a life expectancy of at least 6 months, meet safety lab values for treatment, and not be pregnant or breastfeeding. Participants must agree to use effective contraception and have measurable tumors that haven't been treated with radiation.

What is being tested?

The trial is testing if a PET/CT scan using zirconium Zr 89 crefmirlimab berdoxam can predict how well these cancers will respond to immunotherapy treatments. It's for patients who are receiving immunotherapy as their first or second line of treatment.

What are the potential side effects?

Potential side effects aren't specified here but generally include reactions related to the injection site such as pain or swelling, allergic reactions to the tracer substance used in imaging scans, and any risks associated with additional exposure to radiation from the PET/CT scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself and doctors expect me to live at least 6 more months.

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I have advanced melanoma or Merkel cell carcinoma and can't be treated with surgery.

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I have a measurable cancer lesion that has not been treated with radiation.

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My cancer has a mutation like KRAS G12C that responds well to specific immune treatments.

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I have advanced kidney cancer that can't be removed by surgery and am eligible for certain drug treatments.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer is only in the bones and doesn't show up in soft tissues on scans.

Select...

My cancer does not only affect my skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to at least 24 or 27 weeks after the start of iot, depending on treatment schedule.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to at least 24 or 27 weeks after the start of iot, depending on treatment schedule.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to at least 24 or 27 weeks after the start of iot, depending on treatment schedule. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)

Secondary study objectives

12-lead ECG Overall Result

12-lead ECG PR interval (msec)

12-lead ECG QRS interval (msec)

+21 more

Other study objectives

Positron-Emission Tomography

Zirconium

Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT as a predictor of duration of response (DoR).

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with melanoma, Merkel cell, renal cell, or NSCLCExperimental Treatment1 Intervention

Eligible subjects will receive up to three zirconium Zr 89 crefmirlimab berdoxam 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 or slow bolus injection 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 zirconium Zr 89 crefmirlimab berdoxam administration 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 zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for melanoma include immunotherapy and targeted therapy. Immunotherapy, such as checkpoint inhibitors like pembrolizumab and nivolumab, enhances the immune system's ability to attack melanoma cells by blocking proteins that inhibit T-cell activity. Targeted therapies, including BRAF inhibitors (e.g., vemurafenib) and MEK inhibitors (e.g., trametinib), specifically target genetic mutations that drive melanoma growth. These treatments are significant for melanoma patients as they provide more personalized and effective options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.