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CancerPhase 1NCT03396211

A Study to Evaluate Apatinib (Also Known as Rivoceranib) Plus Nivolumab in Participants With Unresectable or Metastatic Cancer

A Phase 1 study testing Apatinib and Nivolumab in people with Cancer, run by Elevar Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-labeled, single-center, Phase I study to evaluate the safety, tolerability, and efficacy of apatinib with nivolumab treatment in participants with unresectable or metastatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Apatinib and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
22 Dec 2017to 16 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented primary diagnosis of histologic- or cytologic-confirmed solid tumor cancer inclusive of gastric adenocarcinoma, renal cell carcinoma, melanoma, non-small cell lung cancer (NSCLC), breast cancer, angiosarcoma, leiomyosarcoma, synovial sarcoma, and alveolar soft part sarcoma or other solid tumor for which anti-Vascular endothelial growth factor receptor (VEGFR)2 targeted therapy could be applicable.
  • Locally advanced unresectable or metastatic disease.
  • Nivolumab treatment naive and able to begin nivolumab treatment concurrently with initiation of apatinib or have received at least 3 doses of nivolumab treatment and are continuing nivolumab therapy.
  • 1 or more measurable lesions per RECIST v1.1.
  • Participants who have adequate bone-marrow, renal and liver function including:
  • Hematologic: absolute neutrophil count ≥ 1,500/ cubic millimetre (mm^3), platelets≥ 100,000/mm^3, hemoglobin ≥ 9.0 grams (g)/ per decilitre (dL) (blood transfusion to meet the inclusion criteria within 2 weeks is not allowed).
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  • Renal: serum creatinine < 1.5× upper limit of normal (ULN); urinary protein should be< 2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then a 24-hour urine or urine protein/creatinine ratio must be collected and must demonstrate <2 g of protein in 24 hours to allow participation in the study.
  • Hepatic: serum bilirubin < 1.5× ULN, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0× ULN(≤ 4.0× ULN, if with liver metastases).
  • Blood coagulation tests: Partial thromboplastin time (PTT) and international normalized ratio (INR) ≤ 1.5× ULN and ≤ 1.5×ULN, respectively.
  • Eastern Cooperative Oncology Group (ECOG) performance status are evaluated to be ≤ 1 (Participants with ECOG performance status of 2 may be enrolled only with advance review and written approval by the medical monitor).
  • Expected survival of ≥ 12 weeks, in the judgement of the investigator.
  • Ability to swallow the study drug tablets.

Who cannot join

  • History of another malignancy within 2 years prior to enrollment, unless it does not pose a significant risk to life expectancy as per the investigator.
  • Central nervous system (CNS) metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to enrollment. Participants are eligible if metastases have been treated and have returned to neurologic baseline or are neurologically stable (except for residual signs or symptoms related to the CNS treatment).
  • Cytotoxic chemotherapy, surgery, radiotherapy or other targeted therapies and checkpoint inhibitors (excluding nivolumab if not nivolumab treatment naive) within 3 weeks (4 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 1 week in case of biopsy) prior to enrollment (adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before enrollment).
  • Any other therapies including biological and approved therapies within 3 half-lives or 3 weeks whichever is longer and have not recovered from all toxicities from the treatment.
  • Therapy with clinically significant systemic anticoagulant or anti thrombotic agents within 7 days prior to enrollment that may prevent blood clotting and, in the investigator's opinion, could place the participants at risk. Maximum dose of 325 milligram (mg)/day of aspirin is allowed.
  • History of bleeding diathesis or clinically significant bleeding within 14 days prior to enrollment.
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  • History of clinically significant thrombosis (bleeding or clotting disorder) within the past 3 months prior to enrollment that, in the investigator's opinion, may place the participant at risk of side effects from anti-angiogenesis products.
  • History of gastrointestinal bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3 months prior to enrollment that, in the investigator's opinion, may place the participant at risk of side effects from anti-angiogenesis products.
  • Myocardial infarction or an unstable angina pectoris within 3 months prior to enrollment.
  • Prior major surgery or fracture within 3 weeks prior to enrollment or presence of any non-healing wound (procedures such as catheter placement are not considered to be major).
  • Participation in any other interventional clinical trial, within 4 weeks prior to enrollment or while participating in this study.
  • Previous treatment with apatinib.
  • Hypersensitivity to apatinib or components of its formulation.
  • History of uncontrolled hypertension ([HTN], blood pressure ≥ 140/90 millimeters of mercury [mmHg]) and change in anti hypertensive medication within 7 days prior to enrollment) that is not well managed by medication and the risk of which may be precipitated by VEGF inhibitor therapy.
  • History of severe adverse events including uncontrolled HTN or other common anti-angiogenesis class drug effects that were related to ramucirumab or bevacizumab discontinuation and/or may indicate a higher risk to the safety of the participant if provided further anti-angiogenesis treatment, in the investigator's opinion.
  • History of symptomatic congestive heart failure (New York Heart Association III-IV), symptomatic or poorly controlled cardiac arrhythmia, complete left bundle branch block, bifascicular block, or any clinically significant ST segment and/or T-wave abnormalities, QTcF>450 msec for males or QTcF > 470 msec for females prior to enrollment.
  • Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19.
  • History of drug or alcohol abuse within past 5 years.
  • Known history of human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
  • Known history of positive tests for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
  • Pregnant or breast-feeding females.
  • Active bacterial infections.
  • Presence of substance abuse, medical, psychological, or social illness(es)that, in the judgement of the investigator, may interfere with the participant's participation or safety, or which may impact the objectives of the study.
  • History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies.
  • Gastrointestinal malabsorption, or any other condition that in the opinion of the investigator might affect the absorption of the study drug.
  • Grade 2 or greater toxicity from ongoing nivolumab treatment and irAE including colitis and pneumonitis, if not nivolumab treatment naive.
  • Active autoimmune disease or a history of known autoimmune disease.
  • History of drug-induced interstitial pneumonitis or severe hypersensitivity to other antibody therapies.
  • Known or underlying medical condition (for example, a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would make the administration of study drug hazardous to the participant or obscure the interpretation of toxicity determination or adverse events.
  • Other conditions that, in the judgement of the investigator, contraindicate study participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sarcoma Oncology Research Center

    Santa Monica, California, 90403

Other trials in United States

About this study

Official title: An Open-Labeled, Phase I Study to Evaluate the Safety and Tolerability of Apatinib With Nivolumab in Patients With Unresectable or Metastatic Cancer

This is an open-labeled, single-center, Phase I study to evaluate the safety, tolerability, and efficacy of apatinib with nivolumab treatment in participants with unresectable or metastatic cancer. Total study duration will be approximately 50 months: 12 months of recruitment plus 6 months of treatment and subsequent survival follow up.

Read the detailed description

Primary objectives:

  • To evaluate the safety and tolerability of apatinib with nivolumab in participants with unresectable or metastatic cancer.
  • To assess efficacy by objective response rate (ORR), best overall response (BOR), time to response (TTR), and duration of response (DoR) per response evaluation criteria for solid tumors (RECIST) v1.1 and/or response evaluation criteria for solid tumors for immune-based therapeutics (iRECIST).
  • To assess disease control rate (DCR), and duration of disease control (DDC) by RECIST v1.1, and/or iRECIST.

Secondary objectives:

  • To evaluate the efficacy of apatinib with nivolumab in participants with unresectable or metastatic cancer as measured by:
  • Overall survival (OS)
  • Progression-free survival (PFS)
  • Event-free survival (EFS)
Conditions
Cancer
Being tested
Apatinib, Nivolumab
Keywords
Metastatic, Unresectable
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Also called Rivoceranib, Apatinib Mesylate

    Apatinib tablets

  • NivolumabDrug

    Also called Opdivo

    Fixed dose of nivolumab given intravenously every 2 weeks

Study groups in NCT03396211
Study groupRoleWhat they receive
Apatinib with NivolumabExperimentalParticipants will receive an oral dose of apatinib once per day with a fixed dose of nivolumab given intravenously every 2 weeks.
Receives: Drug: Apatinib; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to approximately 5 years

  2. Objective Response Rate (ORR): Percentage of Participants who Achieve Confirmed Complete Response (CR) or Partial Response (PR)

    ORR per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and/or iRECIST criteria.

    Measured: Up to approximately 5 years

  3. Best Overall Response Rate (BOR)

    BOR is the best response, according to RECIST v1.1 and/or RECIST criteria, recorded over the duration of the study until disease progression, or recurrence.

    Measured: Up to approximately 5 years

  4. Time To Response (TTR)

    TTR is the time lapsed from enrollment until documented response according to RECIST v1.1 and/or iRECIST criteria.

    Measured: Up to approximately 5 years

  5. Duration of Response (DoR)

    DoR is the time from documented tumor response (PR or CR) until disease progression or death from any cause, whichever occurs first.

    Measured: Up to approximately 5 years

  6. Disease Control Rate (DCR)

    DCR is the proportion of participants with radiologically documented stable or decreased tumor burden per RECIST v1.1 and/or iRECIST criteria.

    Measured: Up to approximately 5 years

  7. Duration of Disease Control (DDC)

    DDC is the time from enrollment until disease progression or death from any cause, whichever occurs first. Disease progression will be evaluated by RECIST v1.1 and/or iRECIST criteria.

    Measured: Up to approximately 5 years

Secondary outcomes (3)

  1. Overall Survival (OS)

    OS is the time from participant enrollment until death from any cause.

    Measured: Up to approximately 5 years

  2. Event Free Survival (EFS)

    EFS is defined as time from enrollment to a > 20% increase tumor size from baseline by RECIST v1.1, development of distant metastatic disease, or death.

    Measured: Up to approximately 5 years

  3. Progression Free Survival (PFS)

    PFS is the time from start of apatinib treatment to either radiological progression or death, whichever occurs first.

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2018
  2. Study start22 Dec 2017
  3. Primary completion28 Oct 2020
  4. Study completion16 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03396211
Sponsor's protocol ID
LSK-AM107
Status last verified
Apr 2023
First submitted
21 Dec 2017
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apatinib and Nivolumab in people with Cancer, run by Elevar Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to approximately 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03396211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.

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Clinical Trial NCT03396211 | AzTrials