CLINICAL TRIALS PROFILE FOR IMJUDO

All Clinical Trials for IMJUDO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05701488 ↗	SIRT With Tremelimumab and Durvalumab for Resectable HCC	Not yet recruiting	AstraZeneca	Phase 1	2023-05-01	The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. The names of the interventions involved in this study are: - Durvalumab (a type of immunotherapy) - Tremelimumab (a type of immunotherapy) - Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)
NCT05701488 ↗	SIRT With Tremelimumab and Durvalumab for Resectable HCC	Not yet recruiting	Sirtex Medical	Phase 1	2023-05-01	The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. The names of the interventions involved in this study are: - Durvalumab (a type of immunotherapy) - Tremelimumab (a type of immunotherapy) - Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)
NCT05701488 ↗	SIRT With Tremelimumab and Durvalumab for Resectable HCC	Not yet recruiting	Jiping Wang, MD, PhD	Phase 1	2023-05-01	The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. The names of the interventions involved in this study are: - Durvalumab (a type of immunotherapy) - Tremelimumab (a type of immunotherapy) - Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)
NCT05809869 ↗	Immunotherapy and Radioembolisation for Metastatic Hepatocellular Carcinoma	Recruiting	Queen Mary Hospital, Hong Kong	Phase 2	2023-02-15	Hepatocellular carcinoma is one of the most intractable primary malignancies in the hepatobiliary and pancreatic tract with a poor overall survival worldwide. Unfortunately, the vast majority of hepatocellular carcinoma patients suffer from advanced unresectable or metastatic disease at diagnosis. Currently targeted therapy alone, or in combination with anti-vascular endothelial growth factor antagonist, is the standard first-line treatment for metastatic hepatocellular carcinoma. On the other hand, there is growing evidence suggesting that radiation therapy (external or internal) with or without immune checkpoint inhibitors can produce or even augment abscopal effect in which the tumours away from the radiation field also show significant tumour shrinkage. The underlying mechanism of eliciting abscopal effect includes the increased antigen presentation by the myeloid cells within the tumour stroma leading to enhanced tumour cell killing. Previous case reports showed that radiation therapy alone can induce abscopal effect in mice and human models. However, a robust and concrete evidence of abscopal effect with combinational immune checkpoint inhibitors and radioembolisation or external radiation therapy in hepatocellular carcinoma is still lacking. This study investigates the efficacy and safety of immune checkpoint inhibitors and radioembolisation as first-line treatment for previously untreated metastatic hepatocellular carcinoma.
NCT05809869 ↗	Immunotherapy and Radioembolisation for Metastatic Hepatocellular Carcinoma	Recruiting	The University of Hong Kong	Phase 2	2023-02-15	Hepatocellular carcinoma is one of the most intractable primary malignancies in the hepatobiliary and pancreatic tract with a poor overall survival worldwide. Unfortunately, the vast majority of hepatocellular carcinoma patients suffer from advanced unresectable or metastatic disease at diagnosis. Currently targeted therapy alone, or in combination with anti-vascular endothelial growth factor antagonist, is the standard first-line treatment for metastatic hepatocellular carcinoma. On the other hand, there is growing evidence suggesting that radiation therapy (external or internal) with or without immune checkpoint inhibitors can produce or even augment abscopal effect in which the tumours away from the radiation field also show significant tumour shrinkage. The underlying mechanism of eliciting abscopal effect includes the increased antigen presentation by the myeloid cells within the tumour stroma leading to enhanced tumour cell killing. Previous case reports showed that radiation therapy alone can induce abscopal effect in mice and human models. However, a robust and concrete evidence of abscopal effect with combinational immune checkpoint inhibitors and radioembolisation or external radiation therapy in hepatocellular carcinoma is still lacking. This study investigates the efficacy and safety of immune checkpoint inhibitors and radioembolisation as first-line treatment for previously untreated metastatic hepatocellular carcinoma.

Clinical Trial Conditions for IMJUDO

Condition Name

Condition Name for IMJUDO
Intervention	Trials
Hepatocellular Carcinoma	2
Hepatocellular Cancer	1
Resectable Hepatocellular Carcinoma	1

Condition MeSH

Condition MeSH for IMJUDO
Intervention	Trials
Carcinoma, Hepatocellular	2
Carcinoma	2
Liver Neoplasms	1

Clinical Trial Locations for IMJUDO

Trials by Country

Trials by Country for IMJUDO
Location	Trials
Hong Kong	1
United States	1

Trials by US State

Trials by US State for IMJUDO
Location	Trials
Massachusetts	1

Clinical Trial Progress for IMJUDO

Clinical Trial Phase

Clinical Trial Phase for IMJUDO
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for IMJUDO
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for IMJUDO

Sponsor Name

Sponsor Name for IMJUDO
Sponsor	Trials
Sirtex Medical	1
Jiping Wang, MD, PhD	1
Queen Mary Hospital, Hong Kong	1

Sponsor Type

Sponsor Type for IMJUDO
Sponsor	Trials
Other	3
Industry	2

IMJUDO (tremelimumab + durvalumab) clinical trials update, market analysis and projection

Last updated: May 3, 2026

What is IMJUDO and how is it positioned?

IMJUDO is the fixed regimen of tremelimumab (a CTLA-4 inhibitor) + durvalumab (a PD-L1 inhibitor). It is used as a combination immunotherapy and is marketed for combination regimens with CTLA-4/PD-(L)1 pathway activity, with label expansion driven by disease-area trials and regimen-level readouts.

Key growth thesis: IMJUDO’s commercial trajectory is tied to (1) durable response and progression-free survival in approved indications, (2) expansion into additional solid-tumor settings via ongoing pivotal programs, and (3) competitive differentiation against PD-1/PD-L1 monotherapies and other CTLA-4 add-ons.

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Which clinical trials drive the next cycle of label and evidence?

Clinical trial updates for IMJUDO are typically organized by (a) regimen-level efficacy, (b) biomarker enrichment, and (c) comparative positioning against standard-of-care (SoC) chemotherapy and PD-(L)1 monotherapies. The next phases of market impact usually track to:

• Pivotal Phase 3 readouts that can support label expansion (new lines of therapy, new tumor stages, or new tumor types).
• Phase 1/2 expansion cohorts that can establish response depth, durability, and manageable safety in broader biomarker-defined populations.
• Combination optimization studies that shift dosing schedules and partner choice (chemotherapy, targeted therapy, radiation, or other immunotherapies).

Commercially meaningful endpoints that typically trigger adoption:

• Overall survival (OS) and progression-free survival (PFS) with clinically acceptable safety.
• Objective response rate (ORR) plus duration of response (DoR) for rapid market capture in settings with high treatment churn.
• Safety profile aligned to outpatient administration and reduced discontinuations.

Operational implication for market forecasts: if Phase 3 trials report OS benefit or clear PFS benefit with robust DoR, the regimen’s addressable population expands and payer coverage pressure eases. If updates land on non-inferiority endpoints or mixed OS signals, uptake tends to slow outside the core SOC niche.

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What is the current market base (payer and provider adoption logic)?

IMJUDO’s addressable market behaves like a specialty oncology regimen with adoption constrained by:

• Line-of-therapy gatekeeping (first-line adoption is more durable than later-line adoption).
• Companion biomarker and eligibility (where specified).
• Safety management capacity (CTLA-4 combinations can require higher toxicity monitoring than PD-(L)1 monotherapy).
• Sequencing dynamics with other PD-(L)1 and combination IO regimens.

Market structure that typically governs pricing and volume:

• First, the center-of-excellence hospitals capture share in early cycles.
• Next, community oncologists adopt once evidence density and reimbursement policy stabilize.
• Uptake accelerates when guideline adoption follows pivotal OS results.

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How does competition shape IMJUDO volume growth?

In PD-(L)1 plus CTLA-4 combination space, competitive pressure comes from:

• Single-agent PD-1/PD-L1 programs with favorable tolerability and broad eligibility.
• Other combination IO regimens that may match efficacy with lower toxicity or simpler administration.
• Chemo-IO standards that are entrenched in front-line settings and maintain high conversion.

IMJUDO’s competitive leverage is its combination effect profile. If trials confirm superior response durability or OS in specific histologies and disease stages, it can defend against PD-1 monotherapy substitution and retain share against chemo-IO alternatives.

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What does a market projection require for IMJUDO?

A rigorous projection uses a standard commercialization model for oncology IO:

1. Diagnosed population by tumor type and stage.
2. Eligible share based on biomarkers, ECOG, and prior lines.
3. Treatment penetration (share of eligible patients selecting IMJUDO).
4. Therapy duration (median treatment duration and stop rules).
5. Pricing and net price realization (rebates, discounts, and payer mix).
6. Forecast horizon that includes label expansions and competitive patent or clinical displacement risk.

Inputs that usually dominate the forecast:

• Clinical readouts that expand indication scope.
• Guideline placement timing post-data publication.
• Safety and discontinuation rates that influence real-world adherence.
• Insurance coverage and formulary status by geography.

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What market projection can be stated without label-by-label numeric inputs?

A precise dollar forecast requires up-to-date label scope, geography-specific pricing, patient incidence, reimbursement policies, and trial-to-label mapping. Those numeric facts are not provided in the request.

Given that constraint, the projection below is stated as a directional and scenario framework tied to identifiable trial-impact mechanics, not as unverifiable revenue figures.

Scenario framework (directional)

• Base case (moderate expansion):

  • IMJUDO maintains core share in approved settings.
  • Label expansions occur only where Phase 3 endpoints show clear clinical benefit.
  • Uptake grows as guideline-driven conversions rise and community formulary adoption follows.

• Upside (broad adoption):

  • OS-positive or PFS-positive readouts with strong DoR in multiple tumor types or earlier lines.
  • Strong biomarker stratification increases eligibility and physician confidence.
  • Lower-than-feared toxicity improves persistence and reduces treatment discontinuation.

• Downside (slower penetration):

  • Mixed or non-confirmatory OS readouts reduce uptake beyond established cohorts.
  • Competitive substitution from PD-(L)1 monotherapy or other IO combinations limits penetration.
  • Safety signals increase discontinuations, reducing net treatment duration and patient retention.

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Which clinical endpoints most likely change commercial outcomes?

Commercially decisive endpoints for IMJUDO-like IO combinations:

• OS benefit: drives rapid guideline adoption and payer acceptance.
• Sustained PFS with durable DoR: supports long-tail responder value and reduces churn.
• Safety/tolerability: impacts real-world dosing continuity and total cycles.

Endpoints that tend to delay expansion:

• ORR without credible DoR improvements.
• Early progression patterns without evidence of long-term survivors.
• Safety signals that require higher discontinuation management.

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What should investors and R&D planners monitor next?

Trial signals to track

• Whether pivotal programs report OS or only surrogate endpoints
• Whether benefit appears across unselected and biomarker-selected cohorts
• Whether CTLA-4 toxicity is manageable at scale (rate of discontinuation, grade 3/4 immune adverse events, steroid use, discontinuation cadence)

Commercial signals to track

• Formulary tier placement in major oncology centers and community networks
• Time-to-guideline placement after pivotal readouts
• Net price realization under payer pressure
• Switch rates away from competing IO combinations

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What is the likely path of label expansion?

A typical pathway for tremelimumab/durvalumab regimens is:

• Start in validated disease settings with strong baseline immunogenicity and clear SoC comparator.
• Expand earlier in the treatment sequence when efficacy supports benefit-risk.
• Broaden to additional histologies when response patterns persist across cohorts.
• Add line-of-therapy refinements based on toxicity management and survival signals.

The next label cycle depends on pivotal readouts translating to clear clinical benefit and manageable safety.

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Key Takeaways

• IMJUDO’s commercial trajectory is driven by regimen-level efficacy evidence and tolerability across solid-tumor settings.
• The next market shifts will follow pivotal Phase 3 OS/PFS readouts and the speed of guideline and formulary uptake.
• Projections should be built on a scenario framework because numerical forecasts require label-by-label scope, pricing, incidence, and reimbursement inputs not provided here.
• The decisive commercial variables are OS confirmation, durability (DoR), and immune-related adverse event management that preserves persistence.

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FAQs

1) What is IMJUDO’s mechanism of action?
IMJUDO combines CTLA-4 inhibition (tremelimumab) with PD-L1 inhibition (durvalumab) to enhance anti-tumor T-cell activation and checkpoint release.

2) What trial outcomes most affect IMJUDO commercial uptake?
Overall survival (OS), progression-free survival (PFS) with credible duration of response (DoR), and manageable immune-related adverse event rates that sustain treatment duration.

3) Why does line-of-therapy matter for IMJUDO revenue?
Earlier-line adoption expands the eligible population and increases persistence. Later-line markets are smaller and more competitive with rapidly evolving IO and chemo-IO standards.

4) What competitive threats are most relevant?
PD-1/PD-L1 monotherapies with favorable tolerability and other combination IO regimens that deliver similar efficacy with lower discontinuation risk.

5) How should IMJUDO market projections be constructed?
Use a model based on eligible patient pools, treatment penetration, duration of therapy, and net price, updated with each label-expanding trial readout.

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References

[1] FDA label and prescribing information for IMJUDO (tremelimumab + durvalumab).
[2] ClinicalTrials.gov listings for tremelimumab and durvalumab combination studies.
[3] EMA product information for IMJUDO (where applicable).
[4] Peer-reviewed Phase 2/3 publications involving tremelimumab plus durvalumab across solid tumors.