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Monoclonal Antibodies

MCLA-145 + Pembrolizumab for Cancer

Phase 1
Waitlist Available
Research Sponsored by Merus N.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed advanced or recurrent/metastatic solid tumors or B-cell lymphomas, considered non-amenable to surgery or other curative treatments
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Burkitt lymphoma, lymphoblastic leukemia/lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukemia
Current serious illness or medical condition including uncontrolled active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests MCLA-145, a new drug, on patients with advanced or spreading cancers. It aims to find out if the drug is safe and effective in helping the immune system fight cancer.

Who is the study for?
This trial is for adults with advanced solid tumors or B-cell lymphomas that can't be removed by surgery or cured with other treatments. Participants must have measurable disease, be in good physical condition (ECOG 0 or 1), and have tried standard therapies without success. They should not have had more than four prior treatment regimens and must have a life expectancy of at least 12 weeks.
What is being tested?
The study is testing MCLA-145, a bispecific antibody, to see if it's safe and effective for cancer patients when given alongside Pembrolizumab (Keytruda). It's an early-phase trial with two parts: first assessing safety and tolerability, then looking at how well the drugs work against the cancer.
What are the potential side effects?
Possible side effects include those commonly associated with immunotherapies like fatigue, skin reactions, flu-like symptoms, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects related to MCLA-145 are still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer cannot be removed by surgery or cured with other treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had up to 4 treatments for my advanced or spreading cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is a specific type of blood cancer.
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I do not have any serious illness or uncontrolled infections.
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I have previously received treatment with drugs targeting PD-L1 or T-cell activation.
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I have experienced severe side effects from previous anti-PD-1 therapy.
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I have an autoimmune disease and have been treated for it in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MCLA-145Experimental Treatment1 Intervention
In Part 1, the dose escalation phase, patients with advanced or recurrent/metastatic solid tumors or B-cell lymphomas will receive escalating doses of MCLA-145 (either Q2W for those patients in treatment at the time of Amendment #4 or Q3W with Amendment #4 approval). Treatment will be with MCLA-145 (monotherapy) for Group A, or in combination with pembrolizumab for Group B, until MTD or RDE is reached. In Part 2, the expansion phase, participants with advanced or metastatic solid tumors will receive intravenous infusion of MCLA-145 either in monotherapy (Group A) or in combination with pembrolizumab (Group B) at the recommended phase II dose every 3 weeks. The duration of each treatment cycle is 21 days
Group II: Group B Combination TreatmentExperimental Treatment2 Interventions
Patients in Group B will be treated with MCLA-145 in Combination with pembrolizumab 200mg Q3W.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab (Keytruda)
2020
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Merus N.V.Lead Sponsor
9 Previous Clinical Trials
2,650 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
388 Previous Clinical Trials
63,397 Total Patients Enrolled
Ernesto Wasserman, MDStudy DirectorMerus N.V.
3 Previous Clinical Trials
720 Total Patients Enrolled
~40 spots leftby Dec 2025
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