Advanced CancerPhase 1/2NivoPlusNCT02423954
Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)
A Phase 1/2 study testing Temsirolimus, Irinotecan and Irinotecan + capecitabine in people with Advanced Cancer and Pancreatic Cancer, run by Western Regional Medical Center at 1 site in United States.
Trial summary
Determine Phase 2 dose of study drug Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Pancreatic Cancer, Renal Cell Cancer
- What is being tested?
- Temsirolimus, Irinotecan and Irinotecan + capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 1 Nov 2017
- Phase
- Phase 1/2
- 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
- Patient at least 18 years old and has definitive histologically or cytologically confirmed metastatic solid tumor.
- Patient has one or more metastatic tumors measurable by CT scan (or PET/CT, if patient is allergic to CT contrast media). Tumor sites that are considered measureable must not have received prior radiation therapy. For metastatic tumors not measurable by CT and/or PET/CT, there needs to be tumor measuring at least 1cm in one dimension by digital calipers on physical exam.
- Patients can be enrolled only on one of the treatment arms on this trial.
- The investigator will select the appropriate treatment arm for the patient with the following requirements: (a) Patients cannot have had prior progression or intolerance on the single agent chemotherapy and then enrolled on an arm with that same single agent chemotherapy plus nivolumab (b) The chemotherapy on the arm selected must be considered standard of care or its components listed in the NCCN guidelines (www.nccn.org) for that cancer type.
- Have recovered from acute toxicities of prior treatment:
- > 3 weeks must have elapsed since receiving any investigational agent.
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- > 2 weeks must have elapsed since receiving any radiotherapy, or ≥ 3 weeks or 5 half-lives whichever is shorter for treatment with cytotoxic or biologic agents ( ≥ 6 weeks for mitomycin or nitrosoureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
- Patient has adequate biological parameters as demonstrated by the following blood counts at time of screening:
- Absolute neutrophil count (ANC) > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 9 g/dL. Subject can be given packed red blood cell transfusion
- Calculated creatinine clearance > 40 ml/min by Cockroft-Gault equation:
- [CreatClear = Sex ((140 - Age) / (SerumCreat)) (Weight / 72); where Sex = 1 for men and 0.85 for women], total bilirubin 1.5 times the upper limit of normal (ULN) range, AST/ALT ≤ 3 times the upper limit of normal (ULN) range.
- Thyroid stimulating hormone (TSH) within institutional normal limits. If TSH is above the upper limit of normal range, then a free T4 within institutional normal limits is acceptable. If thyroid replacement therapy is initiated then patient may be screened and enrolled once the above criterion is met.
- Persistent prior systemic therapy non-hematologic AE grade ≤ 2 (except alopecia or correctable electrolyte abnormality with supplementation)
- Patient has a Karnofsky performance status (KPS) ≥ 70.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 5 months following the last dose of nivolumab and 30 days following the last dose of chemotherapy on this trial on this trial, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial. If a female subject or female partner of a male subject becomes pregnant during this period then patient will be recommended to seek appropriate obstetric care. The study will not be monitoring subjects or female partners of subjects for pregnancy after the last dose of study drug or chemotherapy.
Who cannot join
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Patient has known brain metastases. Baseline imaging of the brain is required within 28 days prior to randomization.
- Prior therapy with a mammalian target of rapamycin (mTOR) inhibitor for the RCC subjects, prior therapy with irinotecan or topotecan for NSCLC subjects, and prior therapy with irinotecan for CRC patients.
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
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- Requiring daily corticosteroid dose ≥ 10 mg prednisone or equivalent per day.
- Patient has undergone major surgery, other than diagnostic surgery (e.g., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
- Patient will be receiving any other anti-cancer therapy during participation in this trial.
- Prior treatment with nivolumab is not allowed. Prior receipt of other PD-1 inhibitors or PD-L1 inhibitors is allowed.
- Active or prior documented autoimmune disease requiring systemic treatment within the past 2 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Treatment Center of America @ Western Regional Medical Center
Goodyear, Arizona, 85338
About this study
Official title: A Phase Ib/II Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)
Determine Phase 2 dose of study drug
Read the detailed description
Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.
- Conditions
- Advanced Cancer, Pancreatic Cancer, Renal Cell Cancer, Non Small Cell Lung Cancer, Colorectal Carcinoma, Endometrial
- Being tested
- Temsirolimus, Irinotecan, Irinotecan + capecitabine, nivolumab
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
Also called Torisel
IrinotecanDrug
Also called Camptosar
Irinotecan + capecitabineDrug
Also called Camptosar + Xeloda
nivolumabDrug
Also called Opdivo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Temsirolimus 25 mg every 14 days + nivolumab Receives: Drug: Temsirolimus; Drug: nivolumab |
| Arm 2 | Experimental | Irinotecan 150 mg/m2 every 14 days + nivolumab Receives: Drug: Irinotecan; Drug: nivolumab |
| Arm 3 | Experimental | Irinotecan + capecitabine + nivolumab irinotecan 175 mg/m2 on day 1 every 14 days + capecitabine 1000 mg PO BID days 1-5 on, days 6-7 off, each 7 day period Receives: Drug: Irinotecan + capecitabine; Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.
phase 2 dosing of nivolumab + chemotherapy
Measured: up to 4 weeks
Secondary outcomes (4)
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Identify adverse Events
Measured: up to 12 months
Response rate by irRC and response evaluation criteria in solid tumors (RECIST) 1.1 criteria1,2
Identify tumor response
Measured: 12 weeks
The overall survival (OS) and progression-free survival (PFS)
Assess time until death after treatment
Measured: up to 12 months
Quantify changes in amount of blood proteins and circulating tumor DNA in patients enrolled on this study
Assess tumor marker levels
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Why it stopped: Investigator no longer at site to enroll patients or write up data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Waypa, MSN, FNP, Study director, Western Regional Medical CenterCynthia Lynch, MD, Principal investigator, Western Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423954
- Sponsor's protocol ID
- WG2015001
- Acronym
- NivoPlus
- Status last verified
- Jun 2018
- First submitted
- 13 Apr 2015
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)
- ClinicalTrials.gov ID
- NCT02423954
- Acronym / sponsor ID
- NivoPlus / WG2015001
- Conditions
- Advanced Cancer, Pancreatic Cancer, Renal Cell Cancer, Non Small Cell Lung Cancer, Colorectal Carcinoma, Endometrial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator no longer at site to enroll patients or write up data
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine Phase 2 dose of study drug
Detailed description
Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Temsirolimus, Drug: nivolumabTemsirolimus 25 mg every 14 days + nivolumab |
| Arm 2 | Experimental | Drug: Irinotecan, Drug: nivolumabIrinotecan 150 mg/m2 every 14 days + nivolumab |
| Arm 3 | Experimental | Drug: Irinotecan + capecitabine, Drug: nivolumabIrinotecan + capecitabine + nivolumab irinotecan 175 mg/m2 on day 1 every 14 days + capecitabine 1000 mg PO BID days 1-5 on, days 6-7 off, each 7 day period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient at least 18 years old and has definitive histologically or cytologically confirmed metastatic solid tumor.
- Patient has one or more metastatic tumors measurable by CT scan (or PET/CT, if patient is allergic to CT contrast media). Tumor sites that are considered measureable must not have received prior radiation therapy. For metastatic tumors not measurable by CT and/or PET/CT, there needs to be tumor measuring at least 1cm in one dimension by digital calipers on physical exam.
- Patients can be enrolled only on one of the treatment arms on this trial.
- The investigator will select the appropriate treatment arm for the patient with the following requirements: (a) Patients cannot have had prior progression or intolerance on the single agent chemotherapy and then enrolled on an arm with that same single agent chemotherapy plus nivolumab (b) The chemotherapy on the arm selected must be considered standard of care or its components listed in the NCCN guidelines (www.nccn.org) for that cancer type.
- Have recovered from acute toxicities of prior treatment:
Key exclusion criteria (12 listed)
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Patient has known brain metastases. Baseline imaging of the brain is required within 28 days prior to randomization.
- Prior therapy with a mammalian target of rapamycin (mTOR) inhibitor for the RCC subjects, prior therapy with irinotecan or topotecan for NSCLC subjects, and prior therapy with irinotecan for CRC patients.
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemsirolimusAlso: Torisel | Drug | Arm 1 |
| IrinotecanAlso: Camptosar | Drug | Arm 2 |
| Irinotecan + capecitabineAlso: Camptosar + Xeloda | Drug | Arm 3 |
| nivolumabAlso: Opdivo | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.
Time frame: up to 4 weeks
phase 2 dosing of nivolumab + chemotherapy
4 secondary outcomes
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Time frame: up to 12 months
Response rate by irRC and response evaluation criteria in solid tumors (RECIST) 1.1 criteria1,2
Time frame: 12 weeks
The overall survival (OS) and progression-free survival (PFS)
Time frame: up to 12 months
Quantify changes in amount of blood proteins and circulating tumor DNA in patients enrolled on this study
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: Investigator no longer at site to enroll patients or write up data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Waypa, MSN, FNP study director
Western Regional Medical Center
Cynthia Lynch, MD principal investigator
Western Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Temsirolimus, Irinotecan and Irinotecan + capecitabine in people with Advanced Cancer and Pancreatic Cancer, run by Western Regional Medical Center 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 15 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Jul 2018. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Investigator no longer at site to enroll patients or write up data). Results are not available in the source record.
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?
The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer. (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2018.