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Immunotherapy cocktail before surgery shows promise against tough cancers

NCT ID NCT04123379

Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding an experimental drug (CCR2/5-inhibitor or anti-IL-8) to the immunotherapy nivolumab before and after surgery could help shrink tumors and improve long-term survival in people with non-small cell lung cancer or liver cancer. 48 participants received the combination before their tumor was removed. The goal was to see a strong immune response in the removed tumor and better survival rates.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

48 people

The number who actually took part.

Started

Mar 2020

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of NSCLC or HCC * Willing to provide blood samples * Willing to undergo leukapheresis at Mount Sinai Hospital or New York Blood Bank * Willing to have excisional or core needle biopsies * At least 18 years of age * ECOG 0-1 * Surgical candidate for resection of their tumor * Agree to use adequate contraception * Adequate organ and marrow function Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 months for a different primary tumor or patients who have received locoregional therapy for the target lesion * Patients receiving any other investigational agents * Patients with metastatic disease for whom the intent of surgery would not be curative * Uncontrolled intercurrent illness * Pregnant or nursing * Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days * Has active autoimmune disease that has required systemic treatment in the past year * Has a known additional malignancy that is progressing and/or requires active treatment * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not the in the best interest of the patient to participate * HIV positive with detectable viral load or anyone not on stable anti-viral regimen * Has known active Hepatitis B * History of allogeneic hematopoietic cell transplantation or solid organ transplantation * Documented allergic or hypersensitivity response to any protein therapeutics * Patients may not have prolonged QRS or QTc

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma Non-small cell lung cancer

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.