Pragmatic clinical trials to optimise immunotherapeutic interventions for patients with refractory cancers

The EU funding opportunity HORIZON-MISS is part of the Horizon Europe program, specifically targeting the optimization of immunotherapeutic interventions for patients with refractory cancers. This initiative includes a total budget of €22.19 million, with individual project funding ranging from €7.00 to €8.00 million. The expected launch date for proposals is February 10, 2026, with a submission deadline set for September 15, 2026. The application process is single-stage, requiring a comprehensive proposal to be submitted directly through the Funding and Tenders Portal. Eligible applicants encompass a wide range of stakeholders including research institutions, universities, healthcare organizations, SMEs, patient representatives, and others across various disciplines. A consortium representing a multidisciplinary approach and regional health authorities is required for the application. The geographical scope includes EU member states and associated countries, emphasizing participation from diverse European regions. The focus of this funding is on pragmatic clinical trials that evaluate the effectiveness of immunotherapies in real-world settings, aimed at generating clinical evidence for healthcare practice. Successful proposals should prioritize patient involvement in trial design, with endpoints centered around patient-reported outcomes and quality of life considerations. While co-funding is not a formal requirement, leveraging resources for in-kind contributions is encouraged, and applicants must consider various social dimensions such as gender and socioeconomic status to achieve equitable outcomes. The nature of support is a lump sum grant which provides financial predictability and simplifies the administrative process. The competitive landscape suggests an estimated success rate of 10 to 39%, inferred from the projected number of applications relative to the expected number of funded projects. Successful candidates will gain access to resources from the Knowledge Centre on Cancer and are expected to collaborate within the EU's "Diagnosis and Treatment" cluster, enriching the broader landscape of cancer research and innovation in Europe. This opportunity symbolizes a strategic investment aimed at improving cancer care and addressing the healthcare demands of European populations.

This is a summary of the EU funding opportunity HORIZON-MISS, which falls under the Horizon Europe (HORIZON) program and specifically supports the implementation of the Cancer Mission (HORIZON-MISS-2026-02). It is a HORIZON Research and Innovation Action (HORIZON-RIA) with a HORIZON Lump Sum Grant [HORIZON-AG-LS] type of Model Grant Agreement (MGA). The deadline model is single-stage, with a planned opening date of 10 February 2026 and a deadline of 15 September 2026 at 17:00:00 Brussels time.

The expected outcomes of proposals submitted under this topic should aim to deliver results that are directed and tailored towards and contribute to all of the following expected outcomes:

Patients with refractory cancers and their caregivers/families will have access to optimised, tailored and affordable immunotherapeutic interventions that increase their quality of life, across European regions, EU Member States and Associated Countries.

Healthcare professionals and academia will have access to clinical evidence, on effectiveness of immunotherapeutic interventions, to deploy evidence-based treatment interventions with improved patient selection that improve outcomes in real life, i.e. in routine healthcare, for patients with refractory cancers who often present with co-morbidities.

National healthcare providers, policymakers and authorities in European regions, EU Member States and Associated Countries will have the evidence to implement and reimburse optimised and affordable immunotherapeutic interventions in their healthcare systems, including in everyday medical practice.

The scope of this opportunity is to address the need for more effective, affordable, and tailored cancer immunotherapeutic interventions for patients with refractory cancers across Europe, considering the increasing demands and spiraling healthcare costs in a complex and fragmented oncology healthcare landscape. Pragmatic clinical trials, which focus on choosing between care options and evaluate the effectiveness of interventions in routine, real-world settings, are central to this opportunity.

Proposals should address all the following:

Conduct randomised or cluster-randomised academic investigator-initiated pragmatic clinical trials that benefit patients with refractory cancers at any stage of the disease, for any cancer subtype, in any age group or part of society to deliver effective, affordable and tailored immunotherapeutic interventions for implementation by healthcare systems at the level of local communities, European regions, EU Member States and Associated Countries.

All data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status or ethnicity. Translational research is limited to supporting biomarker-informed patient stratification and the conduct and analyses of the proposed clinical trial(s).

The primary and secondary endpoints of the pragmatic clinical trials should target overall survival, patient-reported outcomes and quality of life issues considered important by and for cancer patients and their caregivers/families. Such endpoints should be defined together with patients and their caregivers/families through research that stimulates social innovation and supports end-user engagement using participative research models.

The chosen treatment intervention(s) should be adapted to the particular needs of the target population and to the specificities of the provision of care at local, regional, or national level, duly reflecting the diversity across EU Member States and Associated Countries. Furthermore, affordability and accessibility should be taken into account.

Applicants should include an appropriate mix of stakeholders from various disciplines, sectors and regional as well as national health authorities, and provide details of the clinical study(ies) in the dedicated annex using the template provided in the submission system.

The successful proposals are expected to build on resources made available by the Knowledge Centre on Cancer (KCC) to foster EU alignment and coordination.

Successful proposals will be asked to join the 'Diagnosis and Treatment' cluster for the EU Cancer Mission and should include a budget for networking, attendance at meetings, and joint activities. The Commission will facilitate coordination of these activities.

Some examples of treatment interventions include treatment versus active surveillance in patient management, combination of treatment interventions, determination of optimal dose and dose schedule, de-escalation of treatment intervention, comparative effectiveness of different treatment interventions.

Clinical trials should involve health technologies such as medicinal products, medical devices, in-vitro diagnostic medical devices, or surgical/medical interventions tested in humans, independently from commercial interest and for public health benefits.

Stakeholders include physicians, academia, patients and their caregivers, patient representatives, engineers, behavioural scientists, SMEs, business networks, insurance companies, charities and foundations, research organisations, civil society.

The Knowledge Centre on Cancer (KCC) is hosted by the European Commission's Joint Research Centre (JRC), especially through the ’European Guidelines and Quality Assurance Schemes for Breast, Colorectal and Cervical Cancer Screening and Diagnosis‘, and the ’European Cancer Information System (ECIS)’ and the ’European Cancer Inequalities Registry (ECIR).

To address the objectives of the EU Cancer Mission, participants will collaborate in project clusters to leverage EU-funding, increase networking across sectors and disciplines, and establish a portfolio of EU Cancer Mission R&I and policy actions.

Examples of joint activities are research or research capacity, organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate.

General conditions for participation include:

Admissibility Conditions:Proposal page limit and layout described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes and Part B of the Application Form available in the Submission System.

Eligible Countries described in Annex B of the Work Programme General Annexes. Specific provisions exist for non-EU/non-Associated Countries, detailed in the Horizon Europe Programme Guide.

Other Eligible Conditions described in Annex B of the Work Programme General Annexes.

Financial and operational capacity and exclusion described in Annex C of the Work Programme General Annexes.

Evaluation and award:Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

Evaluation and award:Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. The thresholds for each criterion (Excellence, Impact, Implementation) are 4, with a cumulative threshold of 12.

Evaluation and award:Indicative timeline for evaluation and grant agreement described in Annex F of the Work Programme General Annexes.

Legal and financial set-up of the grants:Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021. The granting authority may object to a transfer of ownership or exclusive licensing of results up to 4 years after the action's end, as set out in Annex 5.

Specific conditions are described in Annex G of the Work Programme General Annexes and in the specific topic of the Work Programme.

Application and evaluation forms and model grant agreement (MGA) information:

Application form templates are available in the Submission System.

The standard application form is HE RIA, IA.

Guidance is provided in the HE Programme Guide.

Model Grant Agreements (MGA) include the Lump Sum MGA.

Call-specific instructions, a detailed budget table (HE LS), information on clinical studies (HE), and guidance on lump sums are available.

Additional documents include:

HE Main Work Programme 2026-2027 – 1. General Introduction

HE Main Work Programme 2026-2027 – 12. Missions

HE Main Work Programme 2026-2027 – 15. General Annexes

HE Programme Guide

HE Framework Programme 2021/695

HE Specific Programme Decision 2021/764

EU Financial Regulation 2024/2509

Decision authorising the use of lump sum contributions under the Horizon Europe Programme

Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment

EU Grants AGA Annotated Model Grant Agreement

Funding & Tenders Portal Online Manual

Funding & Tenders Portal Terms and Conditions

Funding & Tenders Portal Privacy Statement

The budget overview for this topic is as follows:

HORIZON-MISS-2026-02-CANCER-01 HORIZON-RIA:€35,000,000, indicative grant amount 8,000,000 to €9,000,000, 4 grants

HORIZON-MISS-2026-02-CANCER-02 HORIZON-RIA:€15,000,000, indicative grant amount around €15,000,000, 1 grant

HORIZON-MISS HORIZON-RIA:€22,186,000, indicative grant amount 7,000,000 to €8,000,000, 3 grants

HORIZON-MISS-2026-02-CANCER-04 HORIZON-RIA:€15,000,000, indicative grant amount around €5,000,000, 3 grants

HORIZON-MISS-2026-02-CANCER-05 HORIZON-IA:€7,000,000, indicative grant amount around €7,000,000, 1 grant

HORIZON-MISS-2026-02-CANCER-06 HORIZON-CSA:€5,000,000, indicative grant amount around €5,000,000, 1 grant

HORIZON-MISS-2026-02-CANCER-07 HORIZON-RIA:€25,000,000, indicative grant amount 5,000,000 to €6,000,000, 5 grants

Partner search announcements can be viewed and edited on the portal. The submission system is planned to open on the date stated on the topic header.

Support is available through the Online Manual, Horizon Europe Programme Guide, Funding & Tenders Portal FAQ, Research Enquiry Service, National Contact Points (NCPs), Enterprise Europe Network, IT Helpdesk, European IPR Helpdesk, CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk, and the European Charter for Researchers and the Code of Conduct for their recruitment.

In summary, this funding opportunity aims to improve the lives of patients with refractory cancers by supporting pragmatic clinical trials focused on immunotherapeutic interventions. It seeks to generate evidence that can be used by healthcare professionals, policymakers, and healthcare systems to implement and reimburse optimized and affordable treatments. The projects should involve a diverse group of stakeholders and contribute to the EU Cancer Mission's objectives through collaboration and networking. The funding is provided as a lump sum, and successful projects will be expected to join the 'Diagnosis and Treatment' cluster of the EU Cancer Mission.

Eligible Applicant Types:The eligible applicant types include physicians, academia, patients and their caregivers, patient representatives, engineers, behavioural scientists, SMEs, business networks, insurance companies, charities and foundations, research organisations, and civil society. The call is open to an appropriate mix of stakeholders from various disciplines, sectors and regional as well as national health authorities.

Funding Type:The primary financial mechanism is a grant, specifically HORIZON Research and Innovation Actions (HORIZON-RIA) and HORIZON Innovation Actions (HORIZON-IA) and HORIZON Coordination and Support Actions (HORIZON-CSA) under the Horizon Europe Programme. Eligible costs will take the form of a lump sum.

Consortium Requirement:A consortium of multiple applicants is required. Applicants should include an appropriate mix of stakeholders from various disciplines and sectors.

Beneficiary Scope (Geographic Eligibility):The geographic eligibility includes European regions, EU Member States, and Associated Countries. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects.

Target Sector:The program targets the health sector, specifically cancer research and innovation, with a focus on immunotherapeutic interventions for patients with refractory cancers.

Mentioned Countries:The opportunity explicitly mentions European regions, EU Member States, and Associated Countries. It also refers to non-EU/non-Associated Countries that may have specific provisions for funding.

Project Stage:The project stage is focused on pragmatic clinical trials, which evaluate the effectiveness of interventions in real-world settings, suggesting a development and validation stage, with the aim of implementation by healthcare systems.

Funding Amount:The funding amounts vary depending on the specific topic within the call:

HORIZON-MISS-2026-02-CANCER-01:€35,000,000 (Contributions: €8,000,000 to €9,000,000, Indicative number of grants: 4)

HORIZON-MISS-2026-02-CANCER-02:€15,000,000 (Contributions: around €15,000,000, Indicative number of grants: 1)

HORIZON-MISS:€22,186,000 (Contributions: €7,000,000 to €8,000,000, Indicative number of grants: 3)

HORIZON-MISS-2026-02-CANCER-04:€15,000,000 (Contributions: around €5,000,000, Indicative number of grants: 3)

HORIZON-MISS-2026-02-CANCER-05:€7,000,000 (Contributions: around €7,000,000, Indicative number of grants: 1)

HORIZON-MISS-2026-02-CANCER-06:€5,000,000 (Contributions: around €5,000,000, Indicative number of grants: 1)

HORIZON-MISS-2026-02-CANCER-07:€25,000,000 (Contributions: €5,000,000 to €6,000,000, Indicative number of grants: 5)

Application Type:The application type is an open call with a single-stage submission process.

Nature of Support:Beneficiaries will receive money in the form of a lump sum grant to support research and innovation actions, innovation actions, and coordination and support actions.

Application Stages:The application process involves a single stage.

Success Rates:The success rates are not explicitly mentioned, but the indicative number of grants for each topic provides some insight into the potential success rate, which would depend on the number of applications received.

Co-funding Requirement:The information does not explicitly state a co-funding requirement.

Summary:This Horizon Europe call (HORIZON-MISS-2026-02) aims to support the implementation of the Cancer Mission by funding projects focused on optimising immunotherapeutic interventions for patients with refractory cancers. The call encompasses several topics, including research and innovation actions, innovation actions, and coordination and support actions. Eligible applicants include physicians, academia, SMEs, patient organisations, and other stakeholders from EU Member States, Associated Countries, and potentially non-EU/non-Associated Countries with specific funding provisions. The projects should conduct pragmatic clinical trials to deliver effective, affordable, and tailored immunotherapeutic interventions, with a focus on improving the quality of life for cancer patients and their families. The funding is provided as a lump sum grant, and successful proposals will be asked to join the 'Diagnosis and Treatment' cluster for the EU Cancer Mission. The call has a single-stage submission process, with a planned opening date of February 10, 2026, and a deadline of September 15, 2026. The funding amounts vary by topic, ranging from €5,000,000 to €35,000,000, with an indicative number of grants ranging from 1 to 5 per topic. The projects should address the needs of patients with refractory cancers, healthcare professionals, and national healthcare providers, contributing to the implementation and reimbursement of optimised immunotherapeutic interventions in healthcare systems.