BridgeMD
A study to learn how mRNA 4359 works in the body and how safe it is in participants with advanced solid tumor cancer when administered alone and in combination with pembrolizumab
EU CTIS ID: 2023-504506-11-00
What this study is testing
For Arm 1, 2a, 2b, 2c: To assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab. For Arm 2d: To assess the antitumor activity of mRNA-4359 in combination with pembrolizumab.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Dose Escalation (Arm 1a): Participant with locally advanced or metastatic cancer (melanoma, NSCLC, NMIBC, HNSCC, MSS CRC, BCC, or TNBC) who have progressed on or are not eligible for prior standard treatments. Measurable disease and biopsy-accessible lesions are required.
- Dose Confirmation (Arm 1b): Participants with CPI-refractory advanced melanoma or NSCLC who have progressed following prior standard therapy. Disease must be measurable and biopsy-accessible. For participants in PD Arm Group 2: PD-L1 positivity (≥1%) is required. For NSCLC participants with known actionable mutations (e.g., EGFR, ALK): prior targeted therapy must have been received or declined. For participants in melanoma Arm 1b expansion cohort: must have centrally confirmed PD-L1 expression (≥1%) from a screening biopsy prior to enrollment.
- Dose Expansion Arms (Arm 2): Participants with locally advanced or metastatic melanoma or NSCLC, with specific biomarker and prior treatment history requirements. For NSCLC, eligibility includes treatment-naïve individuals with PD-L1 TPS ≥50% and no EGFR/ALK alterations. For melanoma, eligibility depends on prior systemic therapy exposure and PD-L1 status, including treatment-naïve and checkpoint inhibitor–refractory cohorts. All participants must have measurable disease per RECIST v1.1 and provide a baseline tumor biopsy. Full eligibility criteria are detailed in the protocol.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Participant has adequate hematological and biological function.
You likely can't join if
- Participant has active central nervous system tumors or metastases.
- For Arm 1b melanoma expansion cohort and Arm 2d participants only: Tumor samples must be recent (≤90 days), technically evaluable, and show PD-L1 TPS ≥1% by central testing. Additionally, there must be no intervening systemic therapy from tumor tissue collection date to the start of trial treatment.
- Participants with Grade >2 neuropathy.
- Participant has received prior radiotherapy within 14 days prior to the first dose of study treatment. A 7 day washout is permitted for palliative radiation.
- Participant has a history of severe allergic reactions to any of the study treatment components.
- Participant has significant heart conditions as defined in the protocol.
See the full eligibility criteria
Who can join
- Dose Escalation (Arm 1a): Participant with locally advanced or metastatic cancer (melanoma, NSCLC, NMIBC, HNSCC, MSS CRC, BCC, or TNBC) who have progressed on or are not eligible for prior standard treatments. Measurable disease and biopsy-accessible lesions are required.
- Dose Confirmation (Arm 1b): Participants with CPI-refractory advanced melanoma or NSCLC who have progressed following prior standard therapy. Disease must be measurable and biopsy-accessible. For participants in PD Arm Group 2: PD-L1 positivity (≥1%) is required. For NSCLC participants with known actionable mutations (e.g., EGFR, ALK): prior targeted therapy must have been received or declined. For participants in melanoma Arm 1b expansion cohort: must have centrally confirmed PD-L1 expression (≥1%) from a screening biopsy prior to enrollment.
- Dose Expansion Arms (Arm 2): Participants with locally advanced or metastatic melanoma or NSCLC, with specific biomarker and prior treatment history requirements. For NSCLC, eligibility includes treatment-naïve individuals with PD-L1 TPS ≥50% and no EGFR/ALK alterations. For melanoma, eligibility depends on prior systemic therapy exposure and PD-L1 status, including treatment-naïve and checkpoint inhibitor–refractory cohorts. All participants must have measurable disease per RECIST v1.1 and provide a baseline tumor biopsy. Full eligibility criteria are detailed in the protocol.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Participant has adequate hematological and biological function.
What rules you out
- Participant has active central nervous system tumors or metastases.
- For Arm 1b melanoma expansion cohort and Arm 2d participants only: Tumor samples must be recent (≤90 days), technically evaluable, and show PD-L1 TPS ≥1% by central testing. Additionally, there must be no intervening systemic therapy from tumor tissue collection date to the start of trial treatment.
- Participants with Grade >2 neuropathy.
- Participant has received prior radiotherapy within 14 days prior to the first dose of study treatment. A 7 day washout is permitted for palliative radiation.
- Participant has a history of severe allergic reactions to any of the study treatment components.
- Participant has significant heart conditions as defined in the protocol.
- Participant has a history of other invasive cancers within the past 3 years, unless treated with curative intent and with no evidence of disease.
- Participants who experienced severe or unresolved adverse events with prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy are excluded. This includes permanent discontinuation due to toxicity, Grade ≥3 immune-related AEs, or neurologic/ocular irAEs of any grade. Full eligibility criteria are detailed in the protocol.
- Participant has active infections such as tuberculosis, hepatitis B, hepatitis C, or HIV. Participants with well-controlled or resolved infections may be eligible, as defined in the protocol.
- Participant has received treatment with prohibited medications or investigational agents within 5 half-lives or 14 days prior to the first day of study intervention, whichever is shorter.
- Participant has required the use of additional immunosuppression other than corticosteroids for the management of an AE, has experienced recurrence of an AE if rechallenged, and currently requires maintenance doses of >10 milligrams (mg) prednisone or equivalent per day.
- Participant has any plan to receive a live attenuated vaccine during study treatment or has received a live vaccine within 30 days before the first dose of study treatment.
- Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline.
- Participants capable of becoming pregnant must use highly effective contraception and must not donate eggs during treatment and for a defined period after the last dose. Sexually active male participants must use condoms and refrain from sperm donation during the same period. Specific timelines are detailed in the protocol.
- Participant has unstable or serious medical conditions (e.g., severe infections, bleeding disorders, GI disease, psychiatric illness) that may compromise their safety, or the protocol compliance are excluded.
- Participant has concurrent enrollment in another interventional clinical study.
- Participant with a diagnosis of ocular/uveal melanoma.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.