Investigator Sponsored Research
Nektar Therapeutics and its subsidiaries (Nektar) has a deep and diverse portfolio of investigational medicines in different stages of clinical development. Our team of dedicated scientists, clinicians and employees are focused on bringing new medicines to patients with debilitating diseases.
As a research-based biopharmaceutical company, Nektar conducts preclinical and clinical studies of our investigational medicine products (IMP) to evaluate them for both safety and efficacy through company sponsored and independently sponsored research such as Investigator Sponsored Research (ISR). ISR is independent research initiated, designed and conducted by qualified investigators, on Nektar IMPs and/or within Nektar’s therapeutic areas of interest. ISR is a component of our clinical research strategy.
By supporting innovative research ideas initiated by qualified investigators, we can advance the medical and scientific knowledge of Nektar’s IMPs. Research conducted through ISR can provide valuable information regarding the safety, efficacy, pharmacology, and tolerability of Nektar's IMPs. Nektar may provide support for ISR in the form of financial support and/or drug supply requests.
NKTR-214 in combination with OPVIDO ® (nivolumab)
Submissions for NKTR-214 in combination with OPDIVO® (nivolumab) related ISR proposals will be accepted
February 4, 2019 through March 1, 2019, closing at 11:59 pm PST
To submit your proposal for an area that is eligible for consideration please click SUBMIT to be directed to our online system
Decisions will be communicated by the first week of April 2019
Clinical and preclinical ISR submissions are currently being accepted for all IMPs; however, please check below for specific submission details for certain IMPs. Nektar support may be available in the form of funding and/or drug supply.
To submit a study proposal through our online system, please review the following checklist for information you will need to provide for your submission. Please note that the form must be filled out completely and submitted in a single session. Partially completed forms cannot be saved for completion at a later time.
- Primary investigator information: first name, last name, email address, phone number
- Institution Information: institution name, address, city, state, postal code, country
- Study Information: study type, subtype, phase, short title, therapeutic area, disease area, planned start date, number of sites and site names, participating countries, planned trial duration, planned number of patients enrolled, local Nektar contact name (if applicable), requested resource, projected costs, primary compounds, primary indication, funding from other sources, government review
- Study details: study rationale, primary objective, primary endpoint, hypothesis, study assessments, secondary objective, data and statistical plan, preclinical/clinical data supporting study, correlative studies (i.e. translational/biomarker), target patient population, specify dose, schedule, duration, and any pre-medications, etc., estimated contract review time, IRB/IAC meeting frequency, sample size calculation and justification, secondary endpoint, planned publication information, if any.
- Unexpected Serious Adverse Reaction (SUSAR) Contacts: SUSAR contact name, SUSAR contact email, SUSAR contact country
- Related documents: Curriculum Vitae (CV), study design schematic (if available), key exclusion/inclusion criteria, references/relevant Literature, supporting documents (if applicable)
Confidential, Proprietary or Confidential Information Excluded
Please do not submit any information to Nektar that is considered confidential, proprietary or private. Submission of a concept does not imply or guarantee endorsement by Nektar. Ultimately, any support provided by Nektar is contingent on an executed research agreement.
Areas of research ELIGIBLE for consideration (either drug + funding, or drug-only):
- Neoadjuvant window-of-opportunity setting across RCC, breast, gastric, sarcoma, and CRC with a translational focus
- 1L BCG-naïve
- MIBC in an enriched biomarker population(s)
- HER2+ Breast
- TNBC (PD-L1 positive, Stage IV, First-Line, IO-naïve)
- NKTR-214 + Nivolumab as a component of a cell-based therapy approach (ie, Adoptive T-cell therapy)
- Rare tumors
- Populations with an emerging biomarker applicable to the combination
Areas of research currently NOT eligible for consideration:
- Triplet combination of NKTR-214 + Nivolumab + Ipilimumab
- Pediatric populations
- Hematologic malignancies
- I-O relapsed/refractory populations
- Proposals exploring different dosing options, routes of administration, and sequencing
- Proposals combining NKTR-214 + Nivolumab with an investigational agent
- Proposals containing only an adjuvant component
- Early-stage trials in NSCLC and Melanoma
- Proposals in Stage IV disease in below tumors:
- TNBC (PD-L1 negative)
- Prostate, H&N, and gynecological cancers
Nektar anticipates acknowledging receipt of all ISR submissions orally or in writing within 10 business days. The review and decision process will be conducted by a team of Nektar’s medical and scientific experts. All decisions will be made based upon current scope of research as well as available resources and research priorities. A formal notification on the status of your application will be sent via email correspondence once a decision had been reached.