Advanced CancerPhase 1POTENTNCT05782361
POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC
A Phase 1 study testing Tepotinib and Pembrolizumab in people with Advanced Cancer and Non Small Cell Lung Cancer, run by Institute of Cancer Research, United Kingdom at 4 sites in United Kingdom.
Trial summary
This clinical study is looking at the combination of two experimental drugs called tepotinib and pembrolizumab. Pembrolizumab, also known as Keytruda, is licenced and available by prescription to treat a variety of cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Tepotinib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 3 May 2023to 9 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female patients aged 18 or over; 2. Non-small cell lung cancer histologically confirmed; 3.
- Part A:
- Either
- Exon 14 MET mutation (on tissue or ctDNA testing); b) Patients have not received prior immunotherapy; c) Patients who have received previous MET inhibitor therapy must have PD-L1 TPS≥50% (not required in those naïve to MET inhibitors).
- Or a) Patient has received at least one line of systemic anticancer therapy for metastatic disease; b) Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose.
- 4.
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- Part B:
- Cohort 1
- Exon 14 MET mutation (on tissue or ctDNA testing); b) Patients have not received prior immunotherapy; c) Patients who have received previous MET inhibitor therapy must have PD-L1 TPS≥50% (not required in those naïve to MET inhibitors).
- 5. Measurable disease as assessed by iRECIST 6. Life expectancy of at least 12 weeks. 7. World Health Organisation (WHO) performance status of 0 or 1(Appendix 1). 8. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP.
- Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x (ULN) unless raised due to tumour in which case up to 5 x ULN is permissible Renal function
- Either:
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Or GFR ≥ 50 mL/min (uncorrected value) Calculated creatinine clearance (using the Wright, Cockcroft \& Gault formula) Coagulation INR < 1.5 APTT <1.5x ULN Unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- 9. Written (signed and dated) study informed consent and be capable of co-operating with treatment and follow-up. If patient does not comply with study procedures such that safety of the trial is affected then they will be withdrawn from the study.
- 10. Female patients with reproductive potential must have a negative urine or serum pregnancy test performed within 7-days prior to start of trial.
Who cannot join
- 1. Endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and four weeks for investigational medicinal products), except for bisphosphonates or RANK ligand antagonists that are permitted for the management of bone metastases. Radiotherapy at radical doses within 6 months and at palliative doses within 2 weeks. Patients already receiving tepotinib prior to trial are not required to cease tepotinib prior to trial entry.
- 2. Ongoing Grade 2 or greater toxicities of previous treatments. Exceptions to this are alopecia and ongoing anticoagulation therapy due to prior thromboembolic episodes.
- 3. History of ILD or interstitial pneumonitis requiring steroid administration. 4. Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have an intra-uterine device and condom) for four weeks before entering the trial, during the trial and for six months afterwards are considered eligible.
- 5. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence effective from the first administration of IMP throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
- NB. Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- 6.
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- Known untreated or active central nervous system (CNS) metastases (progressing or requiring corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
- Evaluable or measurable disease outside the CNS is present.
- Radiographic stability upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the baseline disease assessment
- Not requiring corticosteroids. 7. Major surgery within four weeks of the first dose of study treatment. 8. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- 10. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.
- 11. Has an active autoimmune disease that has required systemic treatment in past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with a history of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis will be excluded from the study. Patients with Sjogren's syndrome will not be excluded from the study. In addition, patients that experienced a Grade 2 or higher immune-related AEs on treatment with immunotherapy will be excluded from the study. Patients with inactive autoimmune disease which has previously required systemic therapy, may be considered on a case-by-case basis after discussion with the chief investigator.
- 12. Has a known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins.
- 13. Has received a live vaccine within 30 days of planned start of study therapy. Note: The killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.
- 14. Has experienced hypersensitivity to tepotinib, pembrolizumab or any of their excipients.
- 15.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive electrocardiograms (ECGs) within 5 minutes of each other. Known congenital QT syndrome or history of torsades de pointes.
- Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete left bundle branch block, third degree heart block. Controlled atrial fibrillation is allowed.
- Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association [NYHA Grade 2 or above], severe valvular disease, uncontrolled hypertension despite optimal therapy.
- Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.
- 17. Current malignancies of other types, with the exception of adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. An exception to this criteria are cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
- 18. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study. Participation in an observational trial would be acceptable.
- 19. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
- 20. Symptoms of active COVID-19 and/or documented active COVID-19 infection at the time of screening.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Lung Unit, Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, M20 4BX
DDU, Royal Marsden Hospital NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: A Proof-of-concept Trial With Safety Run of Tepotinib and Pembrolizumab in NSCLC Patients With and Without MET Exon 14 Mutations (POTENT)
This clinical study is looking at the combination of two experimental drugs called tepotinib and pembrolizumab. Pembrolizumab, also known as Keytruda, is licenced and available by prescription to treat a variety of cancers. Tepotinib is currently licensed in the UK for use in non-small cell lung cancer (NCSLC) and is being investigated for this purpose.
Cancer immunotherapy drugs hold great promise but still do not work for many patients. Laboratory studies on cancers that do not respond well to immunotherapy reveal that most of these tumours do not have any immune cells. This suggests that the cancer has successfully hidden itself and avoided being recognised by the immune system. This study aims to use a novel approach using a targeted drug, tepotinib, to target the gene involved with NSCLC.
Read more
Tepotinib is a type of drug called a kinase inhibitor. Kinase inhibitors are a newer type of drug being used to try to treat cancers. They act by blocking some of the chemical messengers that are part of the signalling process within cancer cells that control their growth. Tepotinib is used in adults to treat NSCLC that can have certain abnormal changes in the mesenchymal-epithelial transition factor gene (MET) and which has spread and/or cannot be removed by surgery. The changes in the MET gene can make an abnormal protein which can lead to uncontrolled cell growth and cancer. By blocking this abnormal protein, tepotinib may slow or stop the cancer from growing as well as potentially shrinking the cancer. This study will include patients with and without the MET exon 14 mutations.
In this clinical study, the investigators aim to test our ideas in a small number of people for the first time, specifically in those patients with cancers which do not respond to cancer immunotherapy.
- Conditions
- Advanced Cancer, Non Small Cell Lung Cancer
- Being tested
- Tepotinib, Pembrolizumab
- Keywords
- tepotinib, pembrolizumab, lung cancer, MET inhibition, immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TepotinibDrug
Tepotinib hydrochloride hydrate will be supplied as film coated tablets. The 250 mg oval, white-pink film-coated tablets contain the excipients mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and Opadry II pink. All formulations are intended for oral administration. Refer to pharmacy manual for formulation and strength information.
PembrolizumabDrug
Also called MK-3475
Pembrolizumab Solution for Infusion 100 mg/vial is a liquid drug product supplied as a clear to opalescent solution, essentially free of visible particles, in Type I glass vials and manufactured using the fully formulated drug substance with L-histidine as buffering agent, polysorbate 80 as surfactant, and sucrose as stabilizer/tonicity modifier.
Pembrolizumab Solution for Infusion can be further diluted with normal saline or 5% dextrose in the concentration range of 1 to 10 mg/mL in IV containers made of polyvinyl chloride (PVC) or non-PVC material.
| Study group | Role | What they receive |
|---|---|---|
| Part A- Escalation | Experimental | The safety run-in part of the study will enrol 6-12 patients. Tepotinib will be given to patients daily for three weeks. After thee weeks, patients will be given pembrolizumab immunotherapy on a 21-day cycle along side tepotinib daily.
Dose de-escalation of Tepotinib only will be performed in in Part A.. Should dose level 1 (500mg OD) be deemed non-tolerable by the SRC then a single dose de-escalation to dose level -1 (250mg OD) may be performed. Alternative dosing schedules may be explored. Recruitment into Part A will be staggered such that at least 7 days elapse between treatment of the 1st and 2nd patient of each dose level. In the dose confirmation phase, the study will first evaluate the dose level 1 with 3 patients, expanding to a maximum of 6 evaluable patients. If needed, a maximum of 6 patients will be evaluate in the dose level -1.
Recruitment to this arm is closed. Receives: Drug: Tepotinib; Drug: Pembrolizumab |
| Part B- Expansion | Experimental | The expansion part of the study will enrol 13-26 patients with NSCLC and MET exon 14 skipping mutations. The combination of tepotinib and pembrolizumab will be tested throughout this part of the study. The first cycle will test the safety run-in of tepotinib followed by the introduction of combination with pembrolizumab from cycle 2 onwards.
Recruitment to this arm is open. Receives: Drug: Tepotinib; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tumour activity evaluation (in Part B)
Assessing the antitumour activity of tepotinib in combination with pembrolizumab using the overall response rate as defined by disease response using iRECIST
Measured: 24 Months
Secondary outcomes (7)
Determination of MTD and RP2D
Establishing the recommended Phase II dose (RP2D) of tepotinib in combination with pembrolizumab by determining a dose at which no more than one patient out of six patients at the same dose level experience a drug-related dose limiting toxicity (DLT).
Measured: 12 Months
Safety and tolerability of the combination of tepotinib with pembrolizumab
Determining causality of each adverse event to the combination of tepotinib with pembrolizumab and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Discontinuation rate defined as number of patients discontinuing IMP due to toxicity
Measured: 24 Months
Further anti-tumour activity evaluation
Evaluating the further measures of antitumour activity of tepotinib in combination with pembrolizumab. Clinical benefit rate defined as the percentage of patient who have achieved complete response, partial response or stable disease according to iRECIST
Measured: 24 Months
Pharmacokinetics of Tepotinib investigating maximum plasma concentration
Determination of the plasma levels of Tepotinib in Part A of the study, using validated assays
Measured: 12 Months
Pharmacodynamics investigating the change in markers of target inhibition
Characterising the pharmacodynamics (PD) profile of tepotinib in combination with pembrolizumab. Determination of changes in markers of target inhibition and immune microenvironment in tumour and blood including T-cell subsets and PD-L1. Analysis will be conducted using the fluorescence activated cell sorting and multi-coloured immunofluorescence.
Measured: 36 Months
Pharmacodynamics investigating the change in ctDNA
Characterising the change in circulating tumour DNA sequencing over trial period for emerging mechanisms of resistance. Determination of allele frequency of genomic aberrations including but not limited to MET, EGFR, BRAF and KRAS in plasma. ctDNA samples will be taken on Day 1 of every cycle.
Measured: 36 Months
Overall survival
Progression-free survival defined as time from cycle 1 day 1 (C1D1) to progressive disease according to iRECIST or death from any cause. The progression-free survival time of patients still alive and progression-free will be censored on the date of their last RECIST assessment.
Overall survival defined as time from C1D1 to death from any cause. Survival time of living patients will be censored on the last date of patient is known to be alive or lost to follow up. Overall survival defined as time from C1D1 to death from any cause. Survival time of living patients will be censored on the last date of patient is known to be alive or lost to follow up.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start3 May 2023
- Primary completion8 Mar 2028 (estimated)
- Study completion9 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Anna Minchom, MD, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782361
- Sponsor's protocol ID
- CCR5558
- Acronym
- POTENT
- Status last verified
- Aug 2025
- First submitted
- 13 Jan 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Trial With Safety Run of Tepotinib and Pembrolizumab in NSCLC Patients With and Without MET Exon 14 Mutations (POTENT)
- ClinicalTrials.gov ID
- NCT05782361
- Acronym / sponsor ID
- POTENT / CCR5558
- Conditions
- Advanced Cancer, Non Small Cell Lung Cancer
- Keywords
- tepotinib, pembrolizumab, lung cancer, MET inhibition, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Merck KGaA, Darmstadt, Germany
- Study start
- 3 May 2023 (actual)
- Primary completion
- 8 Mar 2028 (estimated)
- Study completion
- 9 Jan 2029 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is looking at the combination of two experimental drugs called tepotinib and pembrolizumab. Pembrolizumab, also known as Keytruda, is licenced and available by prescription to treat a variety of cancers. Tepotinib is currently licensed in the UK for use in non-small cell lung cancer (NCSLC) and is being investigated for this purpose.
Cancer immunotherapy drugs hold great promise but still do not work for many patients. Laboratory studies on cancers that do not respond well to immunotherapy reveal that most of these tumours do not have any immune cells. This suggests that the cancer has successfully hidden itself and avoided being recognised by the immune system. This study aims to use a novel approach using a targeted drug, tepotinib, to target the gene involved with NSCLC.
Tepotinib is a type of drug called a kinase inhibitor. Kinase inhibitors are a newer type of drug being used to try to treat cancers. They act by blocking some of the chemical messengers that are part of the signalling process within cancer cells that control their growth. Tepotinib is used in adults to treat NSCLC that can have certain abnormal changes in the mesenchymal-epithelial transition factor gene (MET) and which has spread and/or cannot be removed by surgery. The changes in the MET gene can make an abnormal protein which can lead to uncontrolled cell growth and cancer. By blocking this abnormal protein, tepotinib may slow or stop the cancer from growing as well as potentially shrinking the cancer. This study will include patients with and without the MET exon 14 mutations.
In this clinical study, the investigators aim to test our ideas in a small number of people for the first time, specifically in those patients with cancers which do not respond to cancer immunotherapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A- Escalation | Experimental | Drug: Tepotinib, Drug: PembrolizumabThe safety run-in part of the study will enrol 6-12 patients. Tepotinib will be given to patients daily for three weeks. After thee weeks, patients will be given pembrolizumab immunotherapy on a 21-day cycle along side tepotinib daily. Dose de-escalation of Tepotinib only will be performed in in Part A.. Should dose level 1 (500mg OD) be deemed non-tolerable by the SRC then a single dose de-escalation to dose level -1 (250mg OD) may be performed. Alternative dosing schedules may be explored. Recruitment into Part A will be staggered such that at least 7 days elapse between treatment of the 1st and 2nd patient of each dose level. In the dose confirmation phase, the study will first evaluate the dose level 1 with 3 patients, expanding to a maximum of 6 evaluable patients. If needed, a maximum of 6 patients will be evaluate in the dose level -1. Recruitment to this arm is closed. |
| Part B- Expansion | Experimental | Drug: Tepotinib, Drug: PembrolizumabThe expansion part of the study will enrol 13-26 patients with NSCLC and MET exon 14 skipping mutations. The combination of tepotinib and pembrolizumab will be tested throughout this part of the study. The first cycle will test the safety run-in of tepotinib followed by the introduction of combination with pembrolizumab from cycle 2 onwards. Recruitment to this arm is open. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Male or female patients aged 18 or over; 2. Non-small cell lung cancer histologically confirmed; 3.
- Either
- Exon 14 MET mutation (on tissue or ctDNA testing); b) Patients have not received prior immunotherapy; c) Patients who have received previous MET inhibitor therapy must have PD-L1 TPS≥50% (not required in those naïve to MET inhibitors).
- Or a) Patient has received at least one line of systemic anticancer therapy for metastatic disease; b) Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose.
- 4.
Key exclusion criteria (26 listed)
- 1. Endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and four weeks for investigational medicinal products), except for bisphosphonates or RANK ligand antagonists that are permitted for the management of bone metastases. Radiotherapy at radical doses within 6 months and at palliative doses within 2 weeks. Patients already receiving tepotinib prior to trial are not required to cease tepotinib prior to trial entry.
- 2. Ongoing Grade 2 or greater toxicities of previous treatments. Exceptions to this are alopecia and ongoing anticoagulation therapy due to prior thromboembolic episodes.
- 3. History of ILD or interstitial pneumonitis requiring steroid administration. 4. Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have an intra-uterine device and condom) for four weeks before entering the trial, during the trial and for six months afterwards are considered eligible.
- 5. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence effective from the first administration of IMP throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
- NB. Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TepotinibTepotinib hydrochloride hydrate will be supplied as film coated tablets. The 250 mg oval, white-pink film-coated tablets contain the excipients mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and Opadry II pink. All formulations are intended for oral administration. Refer to pharmacy manual for formulation and strength information. | Drug | Part A- Escalation, Part B- Expansion |
| PembrolizumabAlso: MK-3475Pembrolizumab Solution for Infusion 100 mg/vial is a liquid drug product supplied as a clear to opalescent solution, essentially free of visible particles, in Type I glass vials and manufactured using the fully formulated drug substance with L-histidine as buffering agent, polysorbate 80 as surfactant, and sucrose as stabilizer/tonicity modifier. Pembrolizumab Solution for Infusion can be further diluted with normal saline or 5% dextrose in the concentration range of 1 to 10 mg/mL in IV containers made of polyvinyl chloride (PVC) or non-PVC material. | Drug | Part A- Escalation, Part B- Expansion |
Primary outcome
Anti-tumour activity evaluation (in Part B)
Time frame: 24 Months
Assessing the antitumour activity of tepotinib in combination with pembrolizumab using the overall response rate as defined by disease response using iRECIST
7 secondary outcomes
Determination of MTD and RP2D
Time frame: 12 Months
Safety and tolerability of the combination of tepotinib with pembrolizumab
Time frame: 24 Months
Further anti-tumour activity evaluation
Time frame: 24 Months
Pharmacokinetics of Tepotinib investigating maximum plasma concentration
Time frame: 12 Months
Pharmacodynamics investigating the change in markers of target inhibition
Time frame: 36 Months
Pharmacodynamics investigating the change in ctDNA
Time frame: 36 Months
Overall survival
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Minchom, MD principal investigator
Royal Marsden Hospital NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tepotinib and Pembrolizumab in people with Advanced Cancer and Non Small Cell Lung Cancer, run by Institute of Cancer Research, United Kingdom at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tumour activity evaluation (in Part B) (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.