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New drug shows promise in helping immune system fight advanced cancers

NCT ID NCT04181788

Disease control Sponsor: Pfizer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called PF-06801591 in 155 people with advanced solid tumors or non-small-cell lung cancer. The drug works by blocking a protein that stops the immune system from attacking cancer cells. The goal was to check safety, how the drug moves through the body, and whether it can shrink tumors. Results will help decide if larger studies are worthwhile.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PF-06801591 (a drug that helps the immune system attack cancer cells)
What this could lead to
If successful, this could provide a new treatment option for advanced cancers, especially non-small-cell lung cancer, by helping the immune system fight tumors.
What could go wrong
This is an early-phase trial (Phase 1b/2) with a small number of participants, so results may not apply to all patients. Immune-related side effects are possible, and the drug may not work for everyone.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

155 people

The number who actually took part.

Started

Mar 2020

Finished

May 2026

Lead sponsor

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

18 years and older

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: * Age ≥18 years (≥ 20 years in Japan; ≥ 19 years in South Korea) * Easter Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate bone marrow function, renal and liver functions Phase 1b * Histological or Cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-PD-1 or PD-L1 agent * Participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type Phase 2 * Participants must have a documented diagnosis of stage III where participants are not candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC * EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not permitted * Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score \[TPS\] ≥1%) or unknown are eligible * Up to 1 line of prior therapy in advanced or metastatic disease settings allowed * Participant should not have received prior treatment with anti PD-1/PD-L1 drugs * At least one measurable lesion as defined by RECIST version 1.1 Exclusion Criteria: * Participants with known symptomatic brain metastases requiring steroids * Participants with Interstitial Lung Disease history or complication * Q-T interval corrected for heart rate QTc \> 450 msec for male participants or QTc \> 470 msec for female participants or QTc \> 480 msec in participants with right bundle branch block. * Hypertension that cannot be controlled by medications (eg, systolic \> 150 mmHg and diastolic \> 90 mmHg) despite optimal medical therapy. * Known or suspected hypersensitivity to active ingredient or excipients of the study drug. * History of Grade ≥3 immune mediated AE (including AST/ ALT elevations that where considered drug related and cytokine release syndrome \[CRS\]) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b only). * Vaccination with live attenuated vaccines within 4 weeks prior to randomization is prohibited; however inactivated vaccines are permitted.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Advanced malignancies Non-small cell lung cancer

Contacts and locations

Locations

  • "Medeya Sumy" LLC

    Sumy, Sumska Oblast, 40021, Ukraine

  • Ars Medika Center, LLC

    Kaliningrad, 236006, Russia

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepion Medical Center

    Khodosovka, Kyivska Oblast, 08173, Ukraine

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142, China

  • Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

    Chelyabinsk, 454087, Russia

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council

    Dnipro, 49102, Ukraine

  • Enlimed Llc

    Kopeysk, 456620, Russia

  • Evimed Llc

    Chelyabinsk, 454048, Russia

  • GBUZ Regional Clinical Hospital of Kaliningrad region

    Kaliningrad, 236016, Russia

  • Gachon University Gil Medical Center

    Incheon, 21656, South Korea

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 201107, China

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Klinika UZI 4D, LLC

    Pyatigorsk, Stavropol Kray, 357502, Russia

  • LLC "AR DI PI Ukraine"

    Dnipro, 49102, Ukraine

  • LLC "Diagnostic center "Energo"

    Saint Petersburg, 196247, Russia

  • LLC Medical Center "Magnit"

    Saint Petersburg, 190005, Russia

  • Limited Liability Company "MedX-ray International Group"

    Pliuty Village, Kyiv Oblast, Ukraine

  • Llc "Mdc Expert"

    Dnipro, 49102, Ukraine

  • Llc "Mss"

    Saint Petersburg, 191025, Russia

  • Llc Lidermed

    Odesa, 65062, Ukraine

  • Llc Medical Center Diamed

    Uzhhorod, 88000, Ukraine

  • Llc Medical Centre

    Odesa, 65006, Ukraine

  • MNPE Central City Clinical Hospital of Uzhhorod City Council

    Uzhhorod, 88000, Ukraine

  • Medical University REAVIZ

    Samara, 443001, Russia

  • Medical University REAVIZ

    Samara, 443011, Russia

  • Medical centre "Verum" Limited Liability Company

    Kyiv, 03039, Ukraine

  • Municipal Non Profit enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Center"

    Sumy, 40022, Ukraine

  • Municipal Non-profit Enterprise "SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC"

    Ivano-Frankivsk, 76018, Ukraine

  • Municipal Non-profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council

    Odesa, 65025, Ukraine

  • NS HI "Road Clinical Hospital of JSC "Russian Railways""

    Saint Petersburg, 195271, Russia

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008, China

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • North-West Medical Center

    Saint Petersburg, 191119, Russia

  • Orenburg Regional Clinical Oncological Dispensary

    Orenburg, 460021, Russia

  • Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center

    Kropyvnytskyi, 25006, Ukraine

  • Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg

    Saint Petersburg, 195271, Russia

  • Private Medical Institution "Euromedservice"

    Pushkin, Sankt-Peterburg, 196603, Russia

  • Road clinical clinic of JSC "RZD"

    Saint Petersburg, 192007, Russia

  • Russian Research Centre for Radiology and Surgical Technologies

    Saint Petersburg, Pesochny, 197758, Russia

  • Russian Scientific Center For Radiology and Surgical Technologies

    Pesochny, 197758, Russia

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Severance Hospital, Yonsei Univ. Health System

    Seoul, 03722, South Korea

  • State budgetary institution of healthcare of Yaroslavl region "Clinical oncology hospital"

    Yaroslavl, Yaroslavl Oblast, 150054, Russia

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The State Institution "Romodanov Neurosurgery Institute,

    Kyiv, 04050, Ukraine

  • Vita Сom LLC

    Kyiv, 03141, Ukraine

  • Мunicipal non-profit enterprise "Zhytomyr Regional Oncology Dispensary" of Zhytomyr Regional Council

    Zhytomyr, 10002, Ukraine

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