Experimental cancer combo shows early promise but study halted
NCT ID NCT04234113
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new drug called nanrilkefusp alfa, which helps activate immune cells, both alone and combined with the immunotherapy pembrolizumab. It included 115 people with various advanced solid tumors that had stopped responding to standard treatments. The study was terminated early, but researchers collected important safety and dosing information.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nanrilkefusp alfa (a lab-made protein that boosts immune cells) and pembrolizumab (an immunotherapy drug)
- What this could lead to
- If successful, this could point toward a new combination treatment for several hard-to-treat cancers by helping the immune system attack tumors more effectively.
- What could go wrong
- This was an early, small phase 1 trial that was terminated, so results are limited. The treatment may cause serious side effects like immune overactivation, and it is unclear if it will work in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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115 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Nov 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Patients with selected histologically or cytologically confirmed advanced and/or metastatic solid tumors who are refractory to or intolerant of existing therapies known to provide clinical benefit for their condition. * ECOG performance score 0-1. Patients with ECOG performance score 2 to be discussed with the sponsor's medical monitor to be agreed for inclusion. * Estimated life expectancy of ≥3 months * Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter) for biologic agents including immuno-oncology therapy and 4 weeks from major surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy * At least one measurable lesion per iRECIST in a non-irradiated port. If in a previously irradiated port, must have demonstrated progression since best response to radiation therapy. * Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy * Adequate organ system function * Negative serum pregnancy test, if woman of child-bearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized). * Accessible tumor tissue available for fresh biopsy Exclusion criteria: * Untreated central nervous system metastases and/or leptomeningeal carcinomatosis * Known additional malignancy that is progressing and/or requires active treatment * Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar) * History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring chronic obstructive pulmonary disease or any chronic inflammatory disease (sarcoidosis etc.) * Has received a live vaccine within 30 days of planned start of study therapy * Absolute white blood cell count ≤2.0 ×10e9/L * Absolute neutrophil count ≤1.0 ×10e9/L * Platelet count ≤100×10e9/L * Pregnant or breastfeeding women * Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy * Specific co-morbidities * Parts B and B1: * Is hypersensitive to any of the ingredients of pembrolizumab drug product (KEYTRUDA®) * History of solid organ transplantation or hematopoietic stem cell transplantation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Léon Bérard
Lyon, France, 69379, France
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Hopital Saint Louis
Paris, 75010, France
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Hôpitaux Universitaires de Marseille Timone
Marseille, 13005, France
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Institut Claudius Regaud
Toulouse, France, 31059, France
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Institut Gustave Roussy
Paris, France, 94805, France
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Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805, France
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče
Brno, Czechia, 65653, Czechia
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University Hospital Sanchinarro
Madrid, 28050, Spain
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15216, United States
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Vall d'Hebron Institute of Oncology
Barcelona, Spain, 08035, Spain
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Yale Cancer Center
New Haven, Connecticut, 06520, United States
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