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Can a Two-Drug combo outsmart advanced cancers?

NCT ID NCT02718066

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial is testing whether adding an experimental drug called HBI-8000 to the immunotherapy nivolumab can safely control advanced melanoma, kidney cancer, and non-small cell lung cancer. The study enrolls adults whose cancers have not responded to prior treatments. Researchers are looking at safety, tumor shrinkage, and how long the benefit might last.

What this could mean

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

Active substance
an experimental drug called HBI-8000 combined with the immunotherapy nivolumab
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial, so the combination may prove too toxic or no more effective than existing treatments. Side effects from both drugs could be severe.

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

96 people

The number who actually took part.

Started

Aug 2016

Finished

Dec 2023

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 Subjects were entered in the study only if they met all of the following criteria: 1\. Adults at least 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 3. 1. Subjects with histopathologically or cytologically confirmed diagnosis of non uveal melanoma, RCC, or NSCLC, for whom the use of nivolumab was indicated. NSCLC subjects with EGFR or ALK genomic aberrations in tumor should have disease progression on FDA approved therapy for these aberrations prior to receiving nivolumab. (Phase 1b). 2. Subjects with histopathologically or cytologically confirmed diagnosis of non uveal melanoma or NSCLC for whom the use of nivolumab is indicated (Phase 2 expansion). With Protocol Amendment 5, subjects with NSCLC were not eligible for enrollment. c, Non uveal melanoma and NSCLC subjects whose disease progressed after achieving stable disease (SD) for at least 3 months, with partial response (PR) or complete response (CR) as the best response that was documented by imaging studies on previous treatment with a PD L1 inhibitor with proven efficacy (Phase 2 expansion). With Protocol Amendment 5, subjects with NSCLC were not eligible for enrollment. 4\. Subject had at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1). Melanoma subjects participating in the optional correlative substudy had tumor tissue available from a metastatic or unresectable site for PD L1 and correlative biomarker analysis. 5\. All prior systemic therapy (chemotherapy, mutation targeting therapy, immune checkpoint therapy), or surgical or radiation treatment was completed at least 4 weeks before study drug\* administration (2 weeks for palliative radiotherapy, 1 week for minor surgery), pending full recovery from therapy. 6\. The following laboratory results within 7 days prior to study drug\* administration: Adequate hematopoietic, electrolyte, hepatic, and renal laboratory findings as defined below: white blood cells (WBC) ≥3000/μL, neutrophils ≥1500/μL, platelets ≥100x103/μL, hemoglobin ≥9.0 g/dL independent of transfusion, creatinine ≤1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), alkaline phosphatase ≤2.5 x ULN (unless bone metastases present), bilirubin ≤1.5 × ULN (unless known Gilbert's disease, where value must be ≤3 × ULN), and serum albumin ≥3.0 g/dL. 7\. Life expectancy ≥12 weeks. 8. A negative serum pregnancy test at baseline for women of childbearing potential. 9\. Were willing to abstain from heterosexual activity or practice physical barrier contraception prior to time of study entry to at least 5 months after the last day of treatment. 10\. Had the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria Subjects who fulfilled any of the following criteria at screening were not eligible for admission into the study: 1. History of Grade 3 or above hypersensitivity reactions to other monoclonal antibodies. 2. Subjects with a history of a cardiovascular illness including: congestive heart failure (New York Heart Association Grade III or IV); unstable angina or myocardial infarction within the previous 6 months; or symptomatic cardiac arrhythmia despite medical management. In addition, for Phase 1b only: QTc (Fridericia's correction) (QTcF) \>450 ms in male, and \>470 ms in female, congenital long QT syndrome. 3. Uncontrolled hypertension, systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg. 4. Subjects with active brain metastasis; previously treated brain metastasis was allowed if it had been stable for 4 weeks or more and had not required steroids. 5. Presence of leptomeningeal disease. 6. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer disease, recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry (except for subjects with a pleurex port), or immune mediated toxicity leading to treatment discontinuation. 7. Active, known, or suspected serious autoimmune disease, except for type I diabetes mellitus, hypothyroidism only requiring hormone replacement, and skin disorders (such as vitiligo, psoriasis, or alopecia). 8. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. 9. Known history of testing positive for human immunodeficiency virus (HIV), known acquired immunodeficiency syndrome (AIDS). 10. Active hepatitis B (serum hepatitis B surface antigen \[HBsAg\] positive) or hepatitis C (hepatitis C virus \[HCV\] antibody test or serum HCV RNA positive) indicating acute or chronic infection. 11. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids were permitted. 12. Use of other investigational agents (drugs not marketed for any indication) within 28 days or at least 5 half lives (whichever is shorter) before study drug administration. 13. Pregnant or breast feeding women. 14. Second malignancy unless in remission for 2 years, except for non melanomatous skin cancer, carcinoma in situ of the cervix treated with curative intent, or curatively treated prostate cancer with prostate specific antigen (PSA) \<0.1 ng/mL. 15. Underlying medical conditions that, in the Investigator's opinion, made the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events. 16. Unwilling or unable to comply with procedures required in this protocol.

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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

  • [Site 01] Hematology - Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952, United States

  • [Site 02] Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • [Site 09] H. Lee Moffitt Cancer Center and Research Institute, Inc.

    Tampa, Florida, 33612, United States

  • [Site 11] University of California, San Diego Medical Center

    La Jolla, California, 92037, United States

  • [Site 12] University of Texas M.D. Anderson Cancer Center - Investigational Cancer Therapeutics

    Houston, Texas, 77030, United States

  • [Site 13] Frederick Memorial Hospital d/b/a James M Stockman Cancer Institute

    Frederick, Maryland, 21702, United States

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