The design of a clinical study matters.
At Merrimack, our highly engineered molecules are developed with a focus on specific adaptation and addiction characteristics. Our studies demand an equal focus on identifying and preselecting patients with the kind of tumors these molecules were created to address.
To that end, our diagnostic tools will provide a basis for all targeted agents in Merrimack studies moving forward.
Ongoing Merrimack Studies
Learn more about our other studies at clinicaltrials.gov.
Investigator Sponsored Trial (IST) Grants
Merrimack’s IST* program supports original, independent, investigator-sponsored research aimed at advancing scientific and clinical knowledge in therapeutic areas of interest to Merrimack. Aligned with that mission, the company reviews unsolicited requests for study drug and/or funding to further the execution of trials of irinotecan liposome (ONIVYDE®,† nal-IRI)* and in select cases, earlier stage product candidates.
We review IST requests on a monthly basis and will strive to provide a decision via email within 6-8 weeks of submission. Decisions are based upon scientific merit, clinical trial accrual history and experience, accomplishments in oncology investigations, as well as alignment with research areas of interest and availability of resources. Concepts should include scientific rationale, preliminary data (if available), study design, and statistical analyses that will support the primary study objectives.
To submit an IST concept for review:
- Download and complete the concept application.
- Email the completed application to merrimackISTgrants@merrimack.com.
*IST proposals related to irinotecan liposome injection (ONIVYDE,† nal-IRI) from investigators or institutions outside of the United States should be referred to our Alliance partners.
PharmaEngine Inc: Holds the rights to commercialize ONIVYDE† in Taiwan.
Baxalta Inc: Holds rights to commercialize ONIVYDE† outside of the United States.
†Click here for full Prescribing Information, including Boxed WARNING.
Access to Investigational Products Outside of a Clinical Trial
Merrimack supports the clinical research process. Through controlled clinical trials in which patients volunteer to participate, we gather data on our investigational products. This data helps Merrimack, regulatory authorities and treating physicians in determining the most appropriate patients to receive the drug. In exceptional cases, Merrimack may permit access to an investigational drug outside of the context of a clinical trial. A treating physician may apply for access to Merrimack’s investigational products on behalf of a patient with a serious or life-threatening condition, who is not eligible for ongoing clinical trials or who has exhausted all other treatment options.
To request access to one of our investigational products, please contact us by email at email@example.com. Merrimack will acknowledge receipt of all requests within 10 business days. Merrimack maintains full discretion over supply of its investigational products and makes no guarantees that requests for access will be approved.
Policy on Access to Investigational Products Outside of a Clinical Trial
This policy applies to compassionate/expanded access to a Merrimack investigational product that is not approved for any purpose in the country where the requested product would be used. This also includes the time between regulatory approval of an investigational product and its commercial availability in a country. Any use of a Merrimack investigational product outside of a clinical trial must be in accordance with local laws and regulations governing such programs, including Merrimack’s policies and procedures. In general, where permitted by local regulation, the investigational product supplied via compassionate access will no longer be provided by Merrimack when it becomes available via the local healthcare system.
Patient Eligibility Criteria
To be eligible for access to a Merrimack investigational product, patients must meet the following criteria:
1. Suffer from a serious or immediately life-threatening disease or condition;
2. Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition;
3. Are ineligible for participation in any ongoing clinical trial of the investigational product, which includes lack of access due to geographic limitations; and
4. Meet any other pertinent medical criteria for access to the investigational product, as established by the Merrimack clinical or medically responsible individual.
Investigational Product Criteria
In addition to the patient eligibility requirements, the Merrimack investigational product must meet the following criteria:
1. The product is under investigation in one or more clinical trials;
2. There is sufficient evidence, as judged by Merrimack, to expect that the potential patient benefit justifies the potential risks of the treatment use, and those potential risks are not unreasonable in the context of the disease or condition to be treated;
3. The provision of the investigational product will not interfere with or compromise the clinical development of the product; and
4. There is adequate supply of the investigational product to perform necessary clinical trials in addition to provide access to patients who do not have alternative treatment options.
Treating Physician Criteria and Responsibilities
The physician attending to the patient who is receiving the Merrimack investigational product must be properly licensed and fully qualified to administer the drug. The physician must agree in writing to comply with:
1. Any applicable country-specific legal and regulatory requirements related to providing an investigational or unlicensed product under compassionate access; and
2. Any Merrimack requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property..