POINTING: Clinical Cohort Study of Patients With Melanoma and NSCLC Receiving Checkpoint Inhibitors

NCT ID: NCT04193956

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2024-09-30

Brief Summary

This is a two-center, prospective continuously accruing longitudinal cohort study in patients with non-small cell lung carcinoma (NSCLC) or metastatic melanoma eligible for standard anti-PD-1 antibody treatment. The data from this prospective longitudinal cohort will be used in the POINTING (towards patient -tailored cancer immunotherapy supported by a multifaceted predictive signature composed of integrative omics and molecular imaging) KWF Kankerbestrijding project (WP4). The goal of this project is to develop a multifaceted predictive signature, by using new techniques on tumor characteristics before and during treatment with immune therapy. To do so, researchers will use the 'omics' approach. By combining molecular omics comprising genomics, transcriptomics, proteomics with radiomics and molecular imaging a set of factors will arise which can accurately predict the outcome of the treatment.

Participants in this cohort will undergo tumor biopsies, venous blood sampling and feces sampling before, during and at the end of standard anti-PD-1 antibody treatment. Also, data derived form routine procedures performed for standard-of-care anti-PD-1 treatment (ao laboratory assessments, CT and FDG-PET) will be collected.

Conditions

Melanoma; Non-Small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

POINTING

Standard-of-care procedures

Intervention Type: OTHER

Patients receive standard of care anti-PD-1 treatment as monotherapy or in combination with other checkpoint inhibitors. Related assessments, as laboratory assessments, CT-thorax-abdomen and FDG-PET will be performed according to clinical routine procedures.

Study procedures

Intervention Type: OTHER

Patients will undergo tumor biopsies, venous blood sampling and feces sampling in combination with a food questionnaire before, during and at the end of standard of care anti-PD-1 treatment.

Interventions

Standard-of-care procedures

Patients receive standard of care anti-PD-1 treatment as monotherapy or in combination with other checkpoint inhibitors. Related assessments, as laboratory assessments, CT-thorax-abdomen and FDG-PET will be performed according to clinical routine procedures.

Intervention Type: OTHER

Study procedures

Patients will undergo tumor biopsies, venous blood sampling and feces sampling in combination with a food questionnaire before, during and at the end of standard of care anti-PD-1 treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytological documented locally advanced or metastatic melanoma or NSCLC.

2. Patients must be eligible for standard treatment with anti-PD-1 antibody treatment (monotherapy or in combination with other checkpoint inhibitors).

3. Age ≥18 years.

4. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions.

5. Metastatic or locally advanced lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.

6. Ability to comply with protocol.

7. Signed Informed Consent form.

Exclusion Criteria

1. Malignancies other than melanoma or NSCLC within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent or ductal carcinoma in situ treated surgically with curative intent).

2. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to study inclusion.

• Patients who have received acute, low-dose, systemic immunosuppressant medications may be enrolled.
• The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

E. G.E. de Vries, MD, PhD

Role: STUDY_CHAIR

University Medical Center Groningen

Locations

NKI-AvL

Amsterdam, , Netherlands

Site Status: RECRUITING

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

E. G.E. de Vries, MD, PhD

Role: CONTACT

e.g.e.de.vries@umcg.nl

+31 50 361 2821

R. S.N. Fehrmann, MD, PhD

Role: CONTACT

r.s.n.fehrmann@umcg.nl

+31 50 361 2821

Facility Contacts

J. B.A.G. Haanen, MD, PhD

Role: primary

j.haanen@nki.nl

+31 20 512 9111

E. G.E. de Vries, MD, PhD

Role: primary

e.g.e.de.vries@umcg.nl

+31 50 361 2821

R. S.N. Fehrmann, MD, PhD

Role: backup

r.s.n.fehrmann@umcg.nl

+31 50 361 2821

Other Identifiers

POINTING

Identifier Type: -

Identifier Source: org_study_id